Global PLM Research - New PLM-IRF Proposal, PLM Citations, The CEO Briefing Document, FDA Compliance

   

2PLM Newsletter

John Stark Associates                                                                                                                                      October 6, 2014 - Vol16 #20

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Global PLM Research - New PLM-IRF Proposal
by Roger Tempest
 
A new Proposal for Support has been published in the quest to establish a PLM International Research Foundation that can fund highly-advanced research into Product Lifecycle Management.

The Proposal builds on the support shown for the global PLM-IRF Survey of researchers at leading universities (2PLM Aug. 25), carried out by the PLM Institute in Geneva. 44 responses were received from 28 countries, highlighting 21 research areas in which the PLM of the future could transcend today's constraints.

The aims of the Proposal are to explain the initiative to industrial companies that might be interested, and to gather support for an open discussion meeting. The first meeting is envisaged for Brussels, which is at the centre of European funding; and this may extend to a series in several different countries.

 
The current lack of advanced PLM research is a significant long-term problem for industrial companies. It means that future PLM capabilities may not support the advanced manufacturing methods that they will want to apply. It may also be a problem for PLM vendors, because separate technological advances such as "thinking components" may mean that current PLM systems become obsolete.

The Proposal charts a course to overcome this. After the current Call for Industrial Support (2PLM Sep. 22), the first open meeting will be arranged with the aim of establishing a 'Pathfinder Group' to develop the Foundation in 2015.

 

You can find more information about the PLM-IRF on the PLMIG web site, or request a copy of the Proposal via plmirf@plmig.com.


 
PLM Citations  
According to Google Scholar, as of September 30 2014, Product Lifecycle Management: Paradigm for 21st Century Product Realisation was the PLM publication most frequently cited in journal articles, technical reports, books and theses.

On September 22 2014, it was cited in Product Data Management Systems as a Tool in Engineering Change Management. This paper by M. Huhtala et al. (Lappeenranta University of Technology, Finland) deals with the techniques that are in use to handle ECs with the help of PDM systems. Details

On September 24 2014, it was cited in V. Fortineau's doctoral dissertation Contribution à une modélisation ontologique des informations tout au long du cycle de vie du produit (Arts et Métiers ParisTech, France). The research of Towards an Ontology-based Infomation Modelling along the Product Lifecycle deals with industrial information modelling in a lifecycle management approach. In this context, achieving semantic interoperability is an important issue to guarantee the quality of information storage, exchange and reuse. Current solutions are based on unification approaches and use standard models as shared information representations. However, unification approches suffer from a lack of expressivity and flexibility. To overcome this issue, ontologies are proposed as a new modelling paradigm in order to perform federative interoperability.


 
This research focuses on inference ontologies and investigates the use of those semantic web-based technologies for a large scale industrial application. An ontology-based framework and a modelling methodology are therefore proposed and evaluated on an industrial use case in the nuclear industry. The application raises modelling issues like the Open World Assumption, the lack of a real integrated rule approach, and the robustness of implementation tools. The industrial use case is implemented within a demonstrator, that finally allows to propose a hybrid solution, where ontologies are locally used. Details

Meanwhile, Global Product: Strategy, Product Lifecycle Management and the Billion Customer Question was cited on September 12 2014 in Product Portfolio Management Requirements for Product Data Management by A. Parviainen (University of Oulu, Finland). Details

In September, Google Scholar also added a citation for Engineering Information Management Systems : Beyond CAD/CAM to Concurrent Engineering Support. It's from a 1995 paper, Process Management in a Data Integrated Design Environment, which presents an approach to supporting cooperative design processes in a data integrated design environment. Details

 

The CEO Briefing Document
by Roger Tempest
 
People look for an "Elevator Pitch" for PLM - an instant explanation of the benefits that will convince a CEO while you share a lift to the sixth floor. This is not possible, and it is not necessary.

PLM projects should get funded because they will deliver significant financial and operational benefits for the company. That needs a thorough justification, which takes time to produce. The PLM Project Justification Handbook explains how to do this, over the course of 74 pages.

However, the problem that "the Board doesn't understand about PLM" still remains. Getting approval for a new PLM project is a selling situation, and if the Customer (CEO or VP on the Approval Board) has a vague doubt in his mind about "this PLM stuff" then he is likely to go round the loop again and again.

What you need is an instant explanation of "What PLM Is". This switches off the doubt, and lets everyone focus instead on the compelling argument you have written into the justification.

 
The CEO Briefing Document does exactly this, in 5 pages of core text. It presents a concise, universal explanation of PLM with highlights to catch the eye of someone who is speed-reading it. Its other useful feature is that the PLM Manager can edit the document before the CEO ever sees it, to add in-house paragraphs that make PLM seem very relevant.

The CEO Briefing Document is part of the PLM Financial Framework toolset, and has been re-published at Version 2.0 together with a separate set of instructions for how to use it effectively.

 

Roger Tempest is co-founder of the PLMIG. Membership of the PLMIG is available via membership@plmig.com


FDA Compliance
by Scott Cleveland
 
ISO 13485 - This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Any discussion about FDA compliance and quality management is ultimately about risk management.

Going through ISO 13485 in detail, I see no less than 40 procedures that need to be written. That includes the process of creating and maintaining the documentation on these 40 procedures.

For the most part, you must have a procedure for everything you do as a company.

Here are some processes that you may not have thought of ....

  • Compliance reviews - You must periodically review your compliance activities
  • Self audits - You must periodically perform self audits
  • Safety - You must have safety processes in place for any of the tasks needed to create and deliver your product or service
  • Training - You must have a training procedure in place
  • Competency - You must have a process in place to ensure competency

 For all of these and any other processes, you must have a process in place to create or change the process. You must have a process in place to review these processes periodically. All of your processes must be documented [including a process to manage the documentation].

Since this is about risk management, you are more than likely to err on the side of caution.

You can do all of this work manually, but an automated system makes it so much easier. An automated system needs to have a process component, a document management component and the ability to do electronic signatures - PLM software has all of the capabilities that you need for any compliance activities, whether it be ISO 9000 for manufacturing or ISO 13485 for a quality management system.

Becoming FDA compliant is a big job that requires many man-hours of effort. Most companies will need help, are you one of them?

Contact me to learn more about PLM and see how it can help your company ....

 

Scott Cleveland can be contacted on +1 408-464-6387


 

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PLM News

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Corporate

Stratasys Ltd. announced the completion of its acquisition of GrabCAD. Details 

Financial

Rand Worldwide, Inc. reported total revenues of $91.6 million for its fiscal year ended June 30, 2014. Details 

People

Simpleware announced the appointment of Theo Verbruggen as Director of Global Sales. Details 

Implementations

Aras announced that Imperial Tobacco Group has selected the Aras PLM suite. Details

AVEVA announced that Tupras is investing in AVEVA software technology. Details

CDS announced that its Catalog as a Service and CAD as a Service solutions has been selected by Buckeye Fasteners. Details

CD-adapco announced a three-year contract, worth over €1M, with FS Dynamics. Details


Centric Software, Inc. announced that Happychic Group has selected Centric Software to provide its product lifecycle management (PLM) software. Details

iSEEK Corp. announced that the Kohler Company selected CADseek Polaris as its shape-based search solution for CAD data management. Details

NGC announced that Rocky Brands has implemented NGC's fashion PLM software. Details

PTC announced that FourthWing selected PTC Creo software. Details

Siemens PLM Software announced that Dongbu Daewoo Electronics has selected Siemens' product lifecycle management (PLM) business to deploy a new PLM system based on its Teamcenter software. Details

TraceParts announced that Phoenix Contact has published over 8,000 products in its Combicon connectors product line to the online platform TracePartsOnline.net. Details

Yunique Solutions announced that Zhejiang Semir Garment Co., Ltd. has selected YuniquePLM. Details 

Developments

Arena Solutions announced its Fall 2014 release, which includes two new modules - Arena Scribe and Arena DataExtract. Details

Dassault Systemes announced SOLIDWORKS 2015. Details

Delcam announced the 2015 version of its Delcam for SolidWorks integrated CAM system. Details

DEM Solutions announced 'EDEM Add-In for ANSYS Workbench'. Details

Informative Graphics Corp. announced Brava! Enterprise 7.2 for IBM Content Navigator. Details

Jetcam announced CrossTrack 3. Details

Lattice Technology, Inc. announced Lattice3D Studio version 13. Details

MSC Software Corp. announced MSC Apex. Details

Open Design Alliance announced a 3D PDF component for Teigha. Details

Sopheon announced Accolade 9.2. Details

ZWCAD Design announced ZWCAD+ 2015. Details

 

Relationships

ANSYS and Modelon announced an agreement. Details

Dassault Systemes and AKKA Technologies announced a partnership. Details 

 Product                         Lifecycle                         Management: Paradigm for 21st Century Product                         Realisation

Polarion Software announced its partnership with Siemens PLM Software. Details

Theorem Solutions and FEI Visualization Sciences Group announced a partnership. Details 

Other

Arena Solutions announced that nine customers have mounted an initial public offering (IPO) and three have been acquired for more than $2 billion each within the last 18 months. Details

Arena Solutions announced that it was presented with a Bronze Stevie Award in the "New Software Product or Service of the Year - Supply Chain Management" category in the 12th Annual American Business Awards. Details

Collier Research Corp. announced that it will demonstrate HyperSizer at CAMX, October 14-16, Orlando, Fla. Details

CONTACT Software announced that it is providing its offering for the early phase of product development and the rapid development and functional validation of model variants through an independent company. To do this, the company founded Fast Concept Modelling & Simulation GmbH, which is headquartered in Munich. Details

E-on Software announced the Personal Learning Edition and Trial Version of PlantFactory, updated for the 2014.6 release. Details

General Motors Co. CEO Mary Barra and her executive leadership team outlined the company's customer-focused strategic plan to become the most valued automotive company at a conference for investors and financial analysts. In 2015, about 27 percent of GM's global sales volume is expected to come from products new or refreshed within 18 months. That figure is expected to rise to 38 percent in 2016 and 2017, and reach 47 percent in 2019. By 2020, the company expects that about 99 percent of global production will be on core architectures. Details

General Motors announced that the GM Innovation Challenge has been launched at four major colleges. Details

2014-09-23 GM announced update of the "GM Recalls Chart" to include General Motors' recalls announced as of Sept. 23, 2014. The "GM 2014 year-to-date North American recalls including exports" chart shows 68 recalls in 2014 with a GMNA & Exports total population of 29,301,427. Details

2014-10-03 General Motors announced that it has updated its list of 2014 recalls through Friday, Oct. 3, 2014. The "GM 2014 year-to-date North American recalls including exports" chart shows 71 recalls in 2014 with a GMNA & Exports total population of 29,943,362. Details

On July 24, 2014, GM announced second quarter results. Net revenue in the second quarter of 2014 was $39.6 billion. EBIT adjusted was $1.4 billion and included the impact of $1.2 billion in recall-related costs. A special charge of $0.4 billion was taken for the GM ignition switch compensation program. .... going forward the company expects recall expense to normalize to a slightly higher rate than it experienced prior to this year, but not materially. The company is changing how it estimates future recall expense and will now accrue at the time of vehicle sale an amount that represents management's best estimate of future recall costs in North America. As a consequence of this change, GM is taking a $0.9 billion non-cash pre-tax special charge in the second quarter for the estimated costs of future possible recalls for up to the next 10 years on 30 million GM vehicles on the road today. Details

Modultek announced Modultek Newsletter 2/2014. Details

TraceParts announced that the global TraceParts engineering community has doubled in size in 4 years. Details

PTC announced that the University of Utah Lassonde Entrepreneur Institute will deliver PTC software and training. Details

Research and Markets announced the September 2014 publication of the "Global Product Data Management Market 2014-2018" report. Analysts forecast the Global Product Data Management market to grow at a CAGR of 10.72 percent over the period 2013-2018. Details

Siemens announced that it will be making a $32 million in-kind software grant to Central Piedmont Community College for its science, technology, engineering and mathematics (STEM) Division. Details

 

 

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