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These are the minimum expectations of a Certified Six Sigma Black Belt.

I: Organization-wide Planning and Deployment

Will understand how to deploy six sigma within a project.
Will be able to implement tools and techniques to deploy strategic directions for initiatives.
Will understand the roles and responsibilities for six sigma projects and how each group influences project deployment- and will be able to support communications about the project deployment.
Will be able to apply operational change management techniques within their defined scope or domain.
II: Organizational Process Management and Measures

Will be able to define various types of benchmarking.
Will be able to describe various types of performance measures- and select an appropriate financial measure for a given situation and calculate its result.
III: Team Management

Will understand the components and techniques used in managing teams- including time management- planning and decision-making tools- team formation- motivational techniques and factors that demotivate a team- performance evaluation and reward.
Will be able to describe elements that can result in a teams success.
Will be able to use appropriate techniques to overcome various group dynamics challenges.
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Will understand the elements of a project charter (problem statement- scope- goals- etc.) and be able to use various tools to track the project progress.
V: Measure

Will be able to define and use process flow metrics and analysis tools to indicate the performance of a process.
Will be able to develop and implement data collection plans- and use techniques in sampling- data capture- and processing tools.
Will be able to define and describe measurement system analysis tools.
Will apply basic probability concepts- and understand various distributions.
Will be able to calculate statistical and process capability indices.
VI: Analyze

Will be able to analyze the results of correlation and regression analyses.
Will be able to define multivariate tools.
Will be able to perform hypothesis tests for means- variances and proportions and analyze their results.
Will understand the components and concepts for ANOVA- Chi-square- contingency tables- and non-parametric tests.
Will understand the elements and purpose of FMEA and use root cause analysis tools.
Will be able to identify and interpret the 7 classic wastes.
Will be able to use gap analysis tools.
VII: Improve

Will be able to define and apply design of experiments (DOE) principles- and distinguish among the various types of experiments.
Will be able to apply various lean tools and techniques to eliminate waste and reduce cycle time.
Will understand how to implement an improved process and how to analyze and interpret risk studies.
VIII: Control

Will be able to apply- use- and analyze the various statistical process control (SPC) techniques.
Will understand total productive maintenance (TPM) and visual factory concepts.
Will be able to develop control plans and use various tools to maintain and sustain improvements.
IX: Design For Six Sigma (DFSS) Framework and Methodologies

Will understand common DFSS and DFX methodologies- and elements of robust designs.



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clinical gadget & Diagnostic business MagazineMDDI Article Index

INTO THE INTERNETOriginally published June 2000

Gabriel Spera

The internet has profoundly modified the way necessities get written and promulgated, making it a lot less complicated for developers around the globe to collaborate, make a contribution, and comply. it be also become plenty less difficult for RA/QA personnel to follow the latest working drafts, and even expect future releases. A wealth of country wide and international regulatory information is available on the web—but only to people who be aware of where to appear. this text will current a short tour of several websites that could be advantageous to any one involved in scientific gadget regulatory affairs and first-rate control.

commercial websites

One in particular positive industrial web page is that of RA information, found at http://www.rainfo.org. The website would not in reality offer any content material by itself—simply hyperlinks to other sources. So, for instance, company will discover FDA enforcement experiences and approval notices, a prolonged list of foreign regulatory components, a directory of regulatory consultants, Federal Register notices, and job postings. Readers can additionally check in for a monthly e-mailed publication protecting regulatory tendencies around the globe.

business ASSOCIATIONS

guidance seekers would additionally do smartly to discuss with the web websites of exchange corporations and professional societies that act as advocates for the scientific gadget business—similar to Regulatory Affairs skilled Society (RAPS), medical gadget producers (MDMA), and fitness business brand's association (HIMA). These companies should still be widely wide-spread already. commonly, they require a membership fee, but supply public access to a couple essential counsel on their websites. continually, participants get entry to guidance that nonmembers don't.

The RAPS site, as an example, can also be discovered at http://www.raps.org. Of chief interest here is the "information and analysis" area, where guests will discover RA catalogs, forms, analysis tools, job postings, member directories, and discussion groups, as well as a hyperlink to the community's month-to-month journal, RA focal point. inside the "research tools" subsection, clients will find the "Reference Desk" and "Regulatory hyperlinks." the previous is for brief answers to basic questions, while the latter is for extra-distinctive investigation of a lot of rules and regulatory agencies. The record of regulatory hyperlinks is pretty huge. In selected, clients will locate links to the most important regulatory their bodies of governments world wide and businesses starting from HIMA to the British Institute of Regulatory Affairs, lots of which could be lined listed here. details of the RAPS certification program for regulatory certified can also be discovered on the website.

HIMA continues a web page at http://www.himanet.com. Most MD&DI readers are already popular with HIMA, a exchange community that lobbies in Washington on behalf of big medical equipment manufacturers. Its web page's "industry substances" section gives some everyday background about the industry, a calendar of upcoming events, vital hyperlinks, an inventory of industry acronyms, and some generally requested questions, or FAQs; the latter are sometimes very useful, and or not it's a good suggestion in general to examine through them on every occasion they appear. HIMA's month-to-month newsletter is also posted, however lots of the articles are handiest obtainable to contributors. (Editor's notice: HIMA has lately changed its identify to AdvaMed, and should keep a brand new site at http://www.advamed.org).

Representing the interests of small device companies, MDMA has a site at http://www.medicaldevices.org. The web page's "news" part showcases the MDMA e-newsletter as well as a listing of press statements. The web site also has a opt for list of trade hyperlinks, most of which should be valuable to RA experts. Like HIMA, MDMA is a lobbying group, so moreover links to industry corporations, market research establishments, and so forth, company will find hyperlinks to government businesses such because the fitness Care Financing Administration.

one other established community, the association for the development of scientific Instrumentation (AAMI), has a site at http://www.aami.org. AAMI is perhaps most famous for its requisites-writing activities, details of which will also be found via following the link marked "requisites." participants can also view public liberate drafts and technical committee experiences right here. The "GMP/QS" link pulls up assistance about AAMI-sponsored courses, conferences, and publications. tips about AAMI's GMP requirements and business observe seminars can also be discovered here, as an example. different files concerning FDA compliance encompass human elements analysis and design manage guidelines. The web site editors additionally post occasional news items on the entrance page.

Equally effective is the FDLI website at http://www.fdli.org. not like HIMA and MDMA, FDLI is not a lobbying neighborhood, however whatever extra of an tips and schooling group, protecting track of regulatory tendencies and working towards personnel in regulatory affairs. FDLI runs a couple of conferences, and information about upcoming seminars is constantly posted on its web site's entrance web page. Going into the website further, one involves the "information Gateway," which holds a listing of lawyers and consultants lively in the trade, together with a further listing of trade acronyms, hyperlinks to government organizations, and different regulatory elements. items of pastime right here include criminal suggestions repositories from a number of universities across the country.

EUROPE

After the united states, Europe is the second-largest market for clinical expertise and a standard launching point for American companies planning to extend remote places. Regulatory approval can frequently be obtained faster in Europe than in the u.s.—however that doesn't mean the regulatory area is less difficult to navigate. a couple of reliable European Union (european) internet websites exist, however these aren't at all times as advantageous as one could hope. Some have too lots advice, others are difficult. moreover, with every site wearing the authentic european brand—a circle of stars on a blue heritage—it can also be tricky to tell the place one web page ends and one other starts.

as an instance, the main ecu web site is Europa, discovered at http://europa.ecu.int/. browsing through this web site might comfortably take hours and even days. friends can gain knowledge of all concerning the Council, the quite a few ministries, the financial and social committee, the ecu ombudsman, and a host of different bureaucratic places of work. however anybody trying to find a particular document or field may still go straight to the search web page and seek it there. If it would not show up, are trying a distinct web page. The time mark downs may be significant. for example, a seek the medical contraptions Directive did locate the textual content of the directive—but a user can be difficult pressed to track it down by using simply following the web page hyperlinks.

Intimately affiliated with Europa is the website of the ecu office of Publications (Eur-OP), determined at http://eur-op.ecu.int/. legit ecu publications are available on the market, and this site is the place they may also be purchased. authentic notices and acts of legislations get written into the professional Journal, which is a little bit corresponding to the U.S. Federal Register. Notices get archived on the EurLex database for 45 days, after which they can be bought via EUDOR, the eu document Repository. As mentioned, the Eur-OP web page is tied to the main Europa web page, and yet a seek the medical devices Directive produced no outcomes.

The EUDOR web site, which will also be found at http://www.eudor.com/, is a different vicinity to order eu files, if they're no longer purchasable without charge. like the Eur-OP web site, this web site has an alternative to look the reliable Journal. in this case, a seek the scientific contraptions Directive did basically produce a reference to the directive, with directions for ordering it.

A greater person-pleasant web site, "the european Union within the US," can also be discovered at http://www.eurunion.org/. This website covers way over simply regulatory affairs. it be geared towards american citizens seeking to export products into the eu. under the heading of "assist," as an instance, visitors will find the site search engine and a beneficial listing of FAQs, including questions involving customs, requirements, highbrow property, and terminology. here is the place guests can learn, as an instance, the answer to the question, "How do I comply with the CE mark requirements for my product once I export to the eu?"

one of the vital most beneficial european sites aren't affiliated with the ecu commission per se. a pretty good instance is DIMDI, a German web site hosted at http://www.dimdi.de/engl/mpgengl/fr-mpge.htm. undoubtedly, the website is geared toward the German market, however much of the counsel applies to the whole ecu market. The web page offers tips about EUDAMED, the German clinical equipment information and classification system. Of most interest is the finished record of equipped authorities and notified bodies; most producers will should contract with a notified body at some factor to profit market clearance in Europe.

also in Germany is a corporation known because the clinical equipment safeguard carrier (MDSS), which has a web site at http://www.mdss.com/welcome.htm. although now not backed with the aid of a executive physique or a trade neighborhood, this website consists of more convenient counsel than most legitimate sites. right on the entrance page, as an example, are particulars in regards to the In Vitro Diagnostics Directive and the clinical instruments Directive, together with quick overviews, news, important hyperlinks, and linked particulars. beneath "news and suggestions," company will discover the record of notified bodies reprinted from the DIMDI web site, in addition to details about labeling and different concerns. once again, most of this tips is geared toward american citizens, as a result of MDSS is hoping to appeal to business as a delegated representative for non-European businesses. beneath "eu Directives," clients will locate a couple of very valuable items—together with the genuine textual content of the clinical instruments Directive, accessible for obtain as a zipped file, and a list of checklists of the basic necessities.

additionally noteworthy is the website of the ecu Confederation of scientific contraptions Associations (EUCOMED)—a european counterpart to HIMA, however its scope may be broader. The site can also be discovered at http://www.eucomed.be/. beneath the "latest concerns" heading, company will find press releases. The "center of attention agencies" part offers advice about separate committees pursuing standardization in areas ranging from legal and regulatory to funding and reimbursement.

throughout the channel is the clinical gadgets agency, the U.ok. counterpart to FDA. Its web site, discovered at http://www.clinical-devices.gov.uk/, has a lot of useful tips—besides the fact that children the arrangement isn't altogether intuitive. as an example, if users need to locate counsel about the medical devices Directive in the A–Z index, they may not locate it beneath M, for scientific, but beneath R, for regulatory tips. once there, although, clients will find all method of assistance documents and linked publications—including some information on knowing and complying with the directive.

additionally value a point out is the Irish scientific equipment association's web page, which will also be found at http://www.eire.org/imda/. The website would not get updated very frequently, but what suggestions is there looks as although it might be advantageous, and the corporation itself can be able to support companies song down requisites and laws selected to ireland.

different foreign websites

though Europe remains the greatest market backyard the us, it be now not the only one it truly is been attracting equipment corporations. happily, many different nations follow the lead of Europe or the us in surroundings regulatory policies.

Canada, for instance, will also be viewed as a bridge between the united states and the ecu. fitness Canada is pretty much the information department of the Canadian Ministry of health, the counterpart to the U.S. FDA. The group has a site at http://www.hc-sc.gc.ca/. On either aspect of the leading web page are lists of one of the issues affecting the Canadian market. Following the "legislation and policy" link in the properly navigation bar, one comes to a listing of public health acts. Of certain interest is the food and drugs Act, which governs clinical contraptions. Scrolling down the page, one also finds a list of medical device assistance files, tips on Canada's healthcare initiatives, and equivalent documents.

scientific instruments Canada is the Canadian equal of HIMA or MDMA. Its web page, which is located at http://www.medec.org/, includes advice about the Canadian regulatory environment, told from the manufacturer's standpoint. right here, too, will also be discovered tips about what a company must do to enter the Canadian market.

one other English-talking part of the world—Australia—presents a vital market for producers seeking to expand foreign places. The Therapeutic goods Administration, which has a web page at http://www.health.gov.au/tga/, is Australia's counterpart to FDA. below the heading "clinical contraptions" may also be found some very specific guidance about Australian regulation of clinical gadgets. In regularly occurring, the country's policy conforms to ecu policy. Australia is also confronting many of the considerations—starting from charge containment to gadget reprocessing— which are affecting markets within the united states.

In Japan, which is probably the third-biggest market for clinical expertise after the U.S. and the european, the Ministry of health and Welfare is the regulatory body. Its professional English-language web site, at http://www.mhw.go.jp/english/index.html, doesn't seem very reputable, nor does it carry a lot assistance in English, however visitors will locate a decent overview of the healthcare gadget and market.

A ultimate overseas web site is that of the world Harmonization task force at http://www.ghtf.org/. The GHTF turned into headquartered by way of the U.S., eu, Canada, Japan, and Australia. every of the project force's look at companies has its own part on the web site—SG1 offers with regulatory techniques, SG2 makes a speciality of postmarket surveillance, SG3 offers with satisfactory techniques, and SG4 handles nice equipment audits. every neighborhood posts working drafts of documents and other gadgets for dialogue and comment.

U.S. substances

As for the U.S. regulatory gadget, most producers have likely already visited the CDRH website at http://www.fda.gov/cdrh. Many, besides the fact that children, can be unaware of the website's electronic reading room, discovered at http://www.fda.gov/foi/electrr.htm. all the most requested FDA files are available there.

additionally of interest are the Federal Register website at http://www.access.gpo.gov/su_docs/aces/aces140.html and http://www.access.gpo.gov/nara/cfr/cfr-desk-search.html, which covers the code of Federal rules. there's additionally http://thomas.loc.gov/, maintained by way of the Library of Congress, where researchers can investigate the status of expenses making their approach during the condominium and Senate.

QA/QC

a couple of effective sites center of attention extra in particular on QA/QC. perhaps the most superb is the American Society for exceptional (ASQ) website, at http://www.asq.org/. The web site has some very effortless primers on ISO and other QA protocols. The society also conducts seminars and workshops, has a certification software for QA/QC authorities, and takes part within the specifications-making procedure. as an instance, it's concerned in ISO/TC 176 on great administration and ISO/TC sixty nine on terminology and symbols. The site's "specifications FAQs" is a very beneficial reference, and the "research and assistance" section gives assistance for conducting research into QA/QC concerns.

one other reference certainly on the ISO collection of requirements is ISO convenient, which has a web site at http://www.isoeasy.org/. probably the most premiere places to beginning is through searching throughout the FAQs, which cover every thing from the way to choose which typical to follow to the way to meet the specific requirements. Like most of the sites outlined to this point, the ISO convenient site gives extra tips to its individuals, an illustration of which is a discussion of the 20 aspects of ISO 9000. visitors will also discover each of the 4 predominant elements of the ISO 9000:2000 revisions clearly laid out.

necessities AND COMPLIANCE

Two greater sites focusing on specifications and compliance deserve mention. the primary is that of national necessities systems network found at http://www.nssn.org/. one of the crucial leading attracts there is the star application, the standards monitoring and reporting service. Subscribers indicate which standards they're attracted to, and obtain automated notification by the use of e-mail on every occasion these necessities are updated, modified, or scheduled for revisions. additionally on the site, below the heading of "assistance resources," are federal govt hyperlinks, ISO updates, and information about other specifications-linked activities.

final up is the Regulatory Compliance suggestions core website at http://www.rcic.com/. it's now not particular to the scientific machine trade, but it surely actually covers it. here, company can locate compliance-linked jobs, colleagues within the field, compliance-connected utility, and compliance-linked news. however the main draw is the "Cyber Compliance Search Engine," which is keyed to search only compliance and regulatory sites. visitors can use it to function a short search, or start to the "laws and standards" area, which is a prekeyed look for international laws and standards. also under the "rules and standards" heading is a listing of some pertinent necessities from worldwide— together with, for example, the textual content of the european–U.S. mutual attention contract.

As a reminder, links to all these websites will also be discovered on scientific DeviceLink. evidently, they elevate much extra information than can also be described listed here, and readers would do neatly to familiarize themselves with at least some of these sites. Spending a couple of minutes when time isn't scarce can save a lot of time when it's.

Gabriel Spera is editor of medical DeviceLink.

Illustration via Garry Nichols/The stock Illustration source

Copyright ©2000 medical equipment & Diagnostic industry


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