Control Engineering’s Process Control Newsletter for March 2002
In this issue:
FDA 21CFR Part 11 awareness poll results
Do you know the answers?
Pulp and paper solutions
Safety system certification update
Conferences, seminars, exhibitions, webcasts
March in Control Engineering
Internet videocast features Jack Welch, former GE CEO
Electronic records and signatures awareness poll results
Thanks to the many people who took the time to share their knowledge of the U.S. Food and Drug Administration’s (FDA) regulation on Electronic Records and Signatures, also known as 21 CFR Part 11. The information you shared was very helpful in guiding my development of the April article appearing in Control Engineering titled ‘I’m From the Government, and I’m Here to Help You!’
The article uses ideas from several expert sources to lay out an electronic records and signatures implementation plan that complies with the FDA regulation in a way that produces measurable business benefits.
Another place survey information is being used is at the April 7-10 World Batch Forum (WBF) conference in Woodcliff, New Jersey.
First thing Tuesday morning (April 9), I will present a few of the findings the poll revealed, and then I have the honor of introducing Mr. Martin Browning, the keynote speaker and one of the authors of the FDA Part 11 regulation. Since authoring the Part 11 regulation, Mr. Martin has started his own company, EduQuest. One of EduQuest’s key customers is the FDA. EduQuest is training FDA inspectors and auditors about 21 CFR Part 11. His presentation is expected to address:
Key requirements of 21 CFR Part 11;
Predicate rules and the impact of 21 CFR Part 11 to existing legacy systems;
The FDA’s approach to evaluating compliance;
How FDA investigators choose systems to inspect;
How the FDA audits computerized systems;
Insights into how FDA investigators think; and
How to better prepare for inspections.
For more information on attending the World Batch Forum conference, visit wbf.org via https://www.wbf.org
Those curious about preliminary poll results, a summary report is posted on AFAB Group’s web site via https://www.afabgroup.com .
Is the FDA serious about enforcement of 21 CFR Part 11? You bet they are! View a few of the recently issued FDA citations pertaining to 21 CFR Part 11 at 23CFRPart11.com via https://www.21cfrpart11.com/pages/fda_docs/fda_docs_warning_letters.htm
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Do you know the answers?
Last month I mentioned I regularly receive questions about the application of instrumentation and controls and had decided that each month I would introduce a few basic instrumentation and control questions.
Last month about a dozen of you sent me your ‘test’ answers and every single one was 100% correct. Congratulations!
Here are the answers to the questions asked in the e-mail version of this month’s newsletter:
1. Match the following formulas to the correct conversion statements:
a. (Deg. C x 9/5) + 32b. (Deg. C + 273.16)c. (Deg. F – 32) x 5/9d. (Deg. F + 459.69)
A. Convert from Fahrenheit to RankinB. Convert from Celsius to FahrenheitC. Convert from Celsius to KelvinD. Convert from Fahrenheit to Celsius
The correct matches are:
a. to B.b. to C.c. to D.d. to A.
2. In flow measurements, the Reynolds number is:
a. A dimensionless number defining the ratio between orifice diameter and pipe diameter.b. A value established by the Reynolds company to define flow measurement types. c. A dimensionless number defining turbulence. d. The production rate of Reynolds aluminum foil.
The correct answer is c.
3. On a piping and instrumentation diagram (P&ID), a circle with a solid horizontal line across it indicates a:
a. Controlled variable b. Panel-mounted or accessible instrument c. Undefined interlockd. Computer-based controller
The correct answer is b:
4. A red thermocouple wire or extension lead is the:
a. Ground b. Negative c. Neutrald. Positive
The correct answer is b:
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Pulp and paper solutions
I’m not sure if it was a special alignment of the planets, some sort of conspiracy, or simply a coincidence, but within a few days in January I received information from three major companies about solutions they were unveiling for the pulp and paper industry.
Honeywell Industry Solutions (Phoenix, Ariz.) introduced its OptiVision Collaborative Suite designed for order fulfillment and production optimization in pulp and paper and flat-sheet industries.
From what I was able to learn, Honeywell’s OptiVision Collaborative Suite is a collection of web-based products designed to provide customer support such as, ad-hoc corporate-wide analysis and reporting, navigation functionality, security, scalability, and a native web user interface. More information is available from Honeywell at iac.honeywell.com .
During the EXFOR 2002 and PAPTAC Conference in Montreal, Quebec, Canada, Invensys Process Systems (Foxboro, Mass.) demonstrated its pulp and paper asset management solution. Invensys solution combines real-time information from the Foxboro I/A Series system with the Invensys Avantis enterprise asset management package to track, analyze, and coordinate plant maintenance activities. The I/A Series system collects plant performance data. Avantis conducts the analysis and automatically triggers alerts to mobilize maintenance and operations before an unexpected shutdown occurs. For more information, visit invensys.com .
Emerson Process Management (Austin, Tex.) introduced ‘Partnering for Pulp & Paper,’ a tailored, results-oriented mill improvement methodology that combines industry expertise, services, and a folio of automation and optimization technologies to deliver guarantees of efficiency improvements. According to Emerson spokespersons, Partnering for Pulp & Paper is applicable for new, upgraded, or existing capital projects and typically produces improvement results in the one to three percent range. Visit https://www.orion-cem.com for more information.
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Safety system certification update
Several months ago I emphasized that end-users need to look past ‘safety certified’ marketing hype and take the time to learn exactly how the instrument or system was certified.
A key thing to keep in mind is that safety standards clearly state that a Safety Integrity Level (SIL) is allocated to a safety instrumented function and not to the individual products or devices making up the safety instrumented function. That means, products such as safety PLCs (programmable logic controllers), sensors, accessories, and valves cannot be certified to meet a given SIL value.
I also challenged suppliers to make copies of their certifications and to keep accompanying certification approval readily available (i.e., on a web site).
Key information contained in each certification approval report includes:
Applicable conditions (restrictions) for use of the product;
Evaluation results of the manufacturer’s safety life-cycle and quality management systems;
Average probability to fail (PFD) on demand;
Testing intervals needed to achieve the average PFD conditions;
Diagnostic coverage and safe failure fraction;
Results of operating software compliance as defined in IEC 61508, Part 3;
Common cause factors based on the IEC 61508 recommended technique;
Diagnostics cycle time for the product (necessary to determine if the product is suitable for a specific safety application);
Results of the fault insertion tests to verify diagnostics and performance of the sub-system(s); and
Review and comments related to environmental testing and compliance to other relevant national and international standards.
Since then I learned that Triconex (Invensys Process Systems, Irvine, Calif.) has posted the Tricon Version 9.0 TUV certificate and accompanying certification approval report, as well as Triconex ‘Safety Consideration Guideline’ document on the TUV Functional Safety (TUV-FS) web site.
I applaud Triconex for taking the initiative to make the certificate and certificate approval report readily available and encourage other safety system suppliers to follow that lead.
View the TUV-FS web site and click on the ‘List of Approved Programmable Electronic Systems (PES) (PLCs).’ Visit Control Engineering to read the article ‘ Look Beyond the Certification, What you don’t ask about products claiming to meet specified SIL requirements could hurt you ‘.
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Conferences, seminars, and exhibitions
Learn from experts in fieldbus technology in a Control Engineering Technology Webcast. Visit /webcast/archives/fieldbus.htm for this free, sponsored webcast: ‘FOUNDATION Fieldbus: An Open, Integrated Architecture for Information Integration.’
Control Engineering’s website includes registration for eight topical e-mailed newsletters, access to exclusive coverage from Control Engineering Europe , site search, Online Control Engineering Buyer’s Guide , and Automation Integrator Guide Online , with advanced search functions.
Control Engineering’s website at / includes links to upcoming conferences, trade shows, and exhibitions:
Mar 18-21, National Industrial Automation, Chicago, Ill.
Apr 7-10, World Batch Forum Conference, Woodcliff Lakes, N.J.
Apr 8-11, Material Handling Show and Conference, Detroit, Mich.
Apr 15-20, Hannover Fair, Hannover Germany
Apr 15-17, Interphex, New York, N.Y.
May 21-23, Sensors Spring Expo, San Jose, Calif.
Jun 3-6, Embedded Systems, Rosemount, Ill.
Jun 4-5, ISPE Washington Conference, Arlington, Va.
Jun 25-27, Integrated Manufacturing Solutions Conference, Cleveland, O.
Sep 8-12, Wonderware Showcase, Orlando, Fla.
Sep 24-26, Sensors Fall Expo, Boston, Mass.
Oct 8-11, Center for Chemical Process Safety Conference, Jacksonville, Fla.
Oct 21-24, ISA Expo, Chicago, Ill.
Nov 3-8, AIChE Annual Meeting, Indianapolis, Ind.
Nov 4-5, ISPE Annual Meeting, Orlando, Fla.
Nov 18-24, Embedded Systems, Boston, Mass.
Nov 19-23, BIAS, Milan, Italy
Nov 20-21, AB Automation Fair, Anaheim, Calif.
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March in Control Engineering
Cover: Editors’ Choice Awards For the 15th year, Control Engineering editors examine a year’s worth of coverage to select the best products. All products selected must have been mentioned in Control Engineering, Control Engineering Online, or Control Engineering e-newsletters during 2001. Criteria for selection includes technological advancement, impact on the market, and service to the industry.
Motion control research study Based on inputs from product specifiers and users, results of a comprehensive survey of the motion control market will be summarized, along with an analysis of ‘megatrends’ as suggested by the responses. Views of key motion-control industry experts will also be included. This is a collaborative project between Control Engineering and Design News. Cahners Economics conducted the survey.
Product Focus: Terminal blocks Original research from Control Engineering/Cahners Research examines trends and user issues with terminal blocks. Recent product descriptions from leading suppliers will be included, along with research survey results.
Back to Basics: Photoelectric sensors Brush up on these basic things to learn (or remember) about photoelectric sensors.
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Internet videocast features Jack Welch, former GE CEO
The first in a series of Internet videocasts from MSI features Jack Welch, former ceo of GE. The exclusive interview, scheduled for April 16 at 10 a.m. CDT, will focus on Welch’s views about issues impacting today’s manufacturing and supply chain environment.
For more on the event and this series of videocasts designed for executives and managers, click on https://manufacturingsystems.com/exec/jwelch02/
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