Bruce McDuffee’s picture

By: Bruce McDuffee

Please tell me how to map this chamber!” This is a plea we hear at every Vaisala current Good Manufacturing Practice (cGMP) seminar. The question deals with environmentally controlled chambers, everything from small refrigerators or freezers, to walk-in chambers or even large warehouses regulated under cGMP rules and guidelines. Attendees who ask the question are usually more interested in how to map a chamber for maximum reliability or effectiveness as opposed to meeting the U.S. Food and Drug Administration (FDA) regulations. Like many of our answers, the first two words of our response are, “It depends.” After the third seminar where this question kept cropping up, we formulated an eight-step guidance document to help answer the question from an effectiveness perspective. An overview is presented here.

Step one: write a validation plan

The first step to mapping a chamber starts at the foundation, and like all foundations, it is the most important and comprehensive step. If your foundation is poor or weak, your structure will eventually fall down. Step one poses several questions that must be asked and answered to ensure a strong foundation for steps two through eight.

Steven Wachs’s picture

By: Steven Wachs

In order to maximize profitability while complying with government regulations regarding net package contents, food manufacturers and packagers must achieve an optimal balance. Consistent overfilling to minimize risk is inefficient and sacrifices profitability, while aggressive filling practices result in significant risks of noncompliance with net contents regulations, in turn leading to potential penalties, loss of reputation, and impaired customer relations. Statistical process control (SPC) and process capability methods may be utilized to determine optimal targets for product fill weights or volumes for a given process. Subsequent focused efforts to minimize variation will allow the target to be further optimized, resulting in less waste without compromising risk.

U.S. regulatory requirements

The specific regulatory requirements for net contents of foods vary by country. This article will address the basic U.S. regulations, although the methods are easily applied to variations of these regulations.

MIT News’s picture

By: MIT News

A new way to analyze how coatings of tiny particles alter the properties of transparent plastic could help researchers create lightweight windows with nearly the strength of glass. The same method could also lead to high-strength, scratch-resistant coatings that could be applied to many different materials, according to the MIT researchers who developed the analysis.

The analysis used a polymer called poly(methyl methacrylate), or PMMA, which is widely used as a glass substitute. Known generically as acrylic, and sold under trademarks such as Lucite or Plexiglas, this material can be brittle and is far less resistant to scratching than glass.

Other researchers have added silica particles measuring just nanometers across to PMMA, creating a polymer-particle nanocomposite with much greater strength. But the MIT team, for the first time, has found a way to analyze the particle-polymer interactions of such coatings at the nanoscale, which could facilitate the discovery of improved coatings. Their work was reported in July 2011 in the journal Soft Matter.

UC Davis’s picture

By: UC Davis

Scientists can now look deeper into new materials to study their structure and behavior, thanks to work by an international group of researchers led by University of California, Davis, and the Lawrence Berkeley National Laboratory (LBNL). The team’s work has been published Aug. 14, 2011, in the journal Nature Materials.

The technique, called angle-resolved photoemission, will enable more detailed study of new types of materials for use in electronics, energy production, chemistry, and other applications.

The technique has been used since the 1970s to study materials, especially properties such as semiconductivity, superconductivity, and magnetism. But it allows probing only to a depth of about 1 nanometer beneath a material’s surface, a limit imposed by the strong inelastic scattering of the emitted electrons.

Mark R. Hamel’s picture

By: Mark R. Hamel

Regular tiered meetings are a staple of any company’s lean management system. The quick stand-up meetings represent part of the daily accountability process which, when combined with leader standard work and visual controls, provide the foundation for sustaining gains, rigorously practicing lean behaviors, aligning the organization, and moving to daily kaizen. Great stuff.

The effectiveness of any tiered meeting is largely driven by the leader. Here, we’re talking about multiple levels of leadership. For example, Tier I usually consists of the natural work team, with the team leader being the supervisor or, well, team leader. Tier II often has a broader composition and focus, and may be led by the value stream leader with line supervision and support folks participating. Tier III may be led by the plant manager, or general manager and have an even wider focus.

The backdrop for tiered meetings is primarily a visual process performance metric board and is supplemented with things like a task accountability board, posted leader standard work, and suggestion status board.

Tim Miller’s default image

By: Tim Miller

Let’s say you’re a facility maintenance manager whose duties include issuing asset preventive-maintenance tickets, ensuring performance of work orders to OSHA standards, fielding emergency equipment breakdowns, minimizing downtime, and measuring all associated costs. Managing a facility’s assets can be complex, so it’s likely that at the heart of your maintenance operations exists a computer installed with computer maintenance management software (CMMS) or enterprise asset management (EAM) software. Today, these legacy programs are proven, invaluable tools for managing a tight ship of daily maintenance activities.

Recent technological leaps within CMMS/EAM software have shifted these legacy programs into the cloud computing space, which is welcome news within facilities management. Shifting to the cloud means that the CMMS/EAM software you count on becomes markedly more valuable.

Ken Vakil’s default image

By: Ken Vakil

The purpose of this article is to discuss automated analysis and report generation of key characteristics measurement data. Key characteristics (KCs) are those features of a part whose measurements must be kept to the nominal values through process control to minimize the "Taguchi Loss." KC measurements are taken using different types of metrology heads, such as laser trackers, or other types of scanners. The actual process discussed in this article requires gathering KC data using laser trackers. The metrology data are imported into software to compare the actual values with their nominal values. Thereafter, the data go through several file format transformations before the reports are created in the format required by the customer.

This article examines current manual processes and proposes an automated solution that can be implemented throughout the entire assembly line.

Key characteristics: definition

Key characteristics are features of a process, tool, part, or assembly that can have a negative impact on product performance (e.g., form, fit, and function) when it varies from its nominal dimension. To be useful, KCs must be quantifiable and measurable.

By: Ray Ryan

The National Institute of Standards and Technology's (NIST) Center for Neutron Research is expanding the number of beamlines for research purposes from seven to 11 beams. The metrology tasks required to perform the installation of the new beamlines include the design and installation of a high-accuracy control network throughout the area affected by the new beamlines, the measurement and fiducialization of 145 new glass guide segments, the alignment of each glass guide segment in its vacuum vessel, and the positioning of the all the vacuum vessels within three distinct areas of the facility.

For the NIST engineers, the project's challenges included a restrictive schedule and severe visibility restrictions within the building. This required careful planning to achieve the required accuracy. This article describes the challenges as well as the methods used by the metrology team to overcome them. The team's efforts provided a highly efficient method of performing the alignment and allowed nonmetrologists to perform the measurement and alignment tasks with minimal assistance.

Dimensional Control Systems DCS’s picture

By: Dimensional Control Systems DCS

Engineers across many manufacturing industries are faced with dimensional engineering challenges as their organizations increase the use of automation on the plant floor.

A critical part of the engineers’ dimensional engineering process involves verifying that the parts being produced meet the tolerances and dimensional specifications they’ve outlined. Yet, cycle-time reductions, resulting from increased automation, have limited the windows of time they have to confirm these “as built” measurements.

This is where having a comprehensive, closed-loop dimensional engineering process in place is not only desirable, but necessary.

Closed-loop solutions

In a closed-loop dimensional engineering process, dimensional data reports are generated as the product enters preproduction and initial runs begin. Users refer to the reports and check key points to ensure that measurement plans are being followed and that end-products achieve the tolerances expected based on the results of all prior steps in the dimensional engineering process. Based on these results, they are able to conduct root cause analyses of any quality issues.

By: Randy Gruver

The buzz surrounding the Coordinate Metrology Society’s (CMS) efforts to bring an industry-recognized certification to the profession of portable 3-D metrology was nearly as prevalent as the buzz about the temperature at this year’s Coordinate Metrology Systems Conference (CMSC) in Phoenix. The CMS certification committee set a goal in 2009 to develop a personnel certification program, and this was our third opportunity to share progress with conference attendees. Our journey began with a vision and a request from industry to leverage the resources of the CMS membership to create a portable 3-D measurement systems personnel certification program.

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