Control Engineering's Process Control Newsletter for March 2002

03/01/2002


In this issue:


 

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 www.wbf.org

Those curious about preliminary poll results, a summary report is posted on AFAB Group's web site via 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 www.21cfrpart11.com/pages/fda_docs/fda_docs_warning_letters.htm

Back to top


 

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) + 32
b. (Deg. C + 273.16)
c. (Deg. F - 32) x 5/9
d. (Deg. F + 459.69)

A. Convert from Fahrenheit to Rankin
B. Convert from Celsius to Fahrenheit
C. Convert from Celsius to Kelvin
D. 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 interlock
d. Computer-based controller

The correct answer is b:

4. A red thermocouple wire or extension lead is the:

a. Ground
b. Negative
c. Neutral
d. Positive

The correct answer is b:

Back to top


 

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 www.orion-cem.com for more information.

Back to top


 

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 '.

Back to top


 

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.

Back to top


 

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.

Back to top


 

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 manufacturingsystems.com/exec/jwelch02/

Back to top



No comments
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
Each year, a panel of Control Engineering editors and industry expert judges select the System Integrator of the Year Award winners.
Control Engineering Leaders Under 40 identifies and gives recognition to young engineers who...
Learn more about methods used to ensure that the integration between the safety system and the process control...
Adding industrial toughness and reliability to Ethernet eGuide
Technological advances like multiple-in-multiple-out (MIMO) transmitting and receiving
Virtualization advice: 4 ways splitting servers can help manufacturing; Efficient motion controls; Fill the brain drain; Learn from the HART Plant of the Year
Two sides to process safety: Combining human and technical factors in your program; Preparing HMI graphics for migrations; Mechatronics and safety; Engineers' Choice Awards
Detecting security breaches: Forensic invenstigations depend on knowing your networks inside and out; Wireless workers; Opening robotic control; Product exclusive: Robust encoders
The Ask Control Engineering blog covers all aspects of automation, including motors, drives, sensors, motion control, machine control, and embedded systems.
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
News and comments from Control Engineering process industries editor, Peter Welander.
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
This is a blog from the trenches – written by engineers who are implementing and upgrading control systems every day across every industry.
Anthony Baker is a fictitious aggregation of experts from Callisto Integration, providing manufacturing consulting and systems integration.
Integrator Guide

Integrator Guide

Search the online Automation Integrator Guide
 

Create New Listing

Visit the System Integrators page to view past winners of Control Engineering's System Integrator of the Year Award and learn how to enter the competition. You will also find more information on system integrators and Control System Integrators Association.

Case Study Database

Case Study Database

Get more exposure for your case study by uploading it to the Control Engineering case study database, where end-users can identify relevant solutions and explore what the experts are doing to effectively implement a variety of technology and productivity related projects.

These case studies provide examples of how knowledgeable solution providers have used technology, processes and people to create effective and successful implementations in real-world situations. Case studies can be completed by filling out a simple online form where you can outline the project title, abstract, and full story in 1500 words or less; upload photos, videos and a logo.

Click here to visit the Case Study Database and upload your case study.