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What are examples of the elements of Quality Control System and the activities of analytical testing?

Question by as57: What are examples of the elements of Quality Control System and the activities of analytical testing?
Our company will be audited by European Medicines Agency this coming May. They asked, “What are the elements of our quality control system? What are the activities of analytical testing, packaging and component testing?” I have a hard time to understand the content of the questions. I was wondering they expect answers, such as calibration verification, and verification of method performance specifications for the first question, and evaluation of analytical methods for the second. If someone can give me some example, that would be a big help. Thanks.

Best answer:

Answer by sixsigmaboss
Yes, you need help fast and this space does not contain enough room to answer everything that you need to get ready for – however, maybe I can get you started –

I am an IRCA QMS 2000 Lead Auditor and very much understand what is being ask!

First – reference materials that you should be aware of:

European Quality Award – http://www.efqm.org/
Malcolm Baldrige National Quality Award – http://www.quality.nist.gov/
ISO – Quality Management System (QMS) 9000 series – http://www.iso.org/iso/home.htm
American Society for Quality (ASQ) – http://www.asq.org

The EFQM and Baldrige are quality awards – these look at the best of the best organizations.

ISO (International Organization for Standardization) standards (which is similar to what you are going through) is set up on a base level that any company or organization should be able to meet.

Your goal should be to get somewhere between what the standards are asking for and the top-level quality awards. The probability is that your organization is already doing a lot of thing very good – also called customer satisfaction.

Now for the quality control system (also called a quality management system). The ISO 9000 series breaks this up into five categories: Quality Manual; Quality Management; Resource Management; Product Realization and the Measurement System. The auditors want to first see what type of a documented system you have to control the overall processes for the business that you are in.

So if you are making some kind of a widget, how has your organization planned to produce what is wanted by the customer, the steps that are gone through to actually make the widget including any product testing of supplier parts or actual components and how the widgets are packaged, shipped and delivered to the customer so that no damage is done to the widget. Once all that is done, how do you know that the customer likes what you sold to them?

Ideally, what you need is some form of documentation (keep is as simple as possible) using the outline of the ISO 9001:2008 below

4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records

5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output

6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment

7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices

8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

Again, this is your starting point. The next thing will be to show the auditors how you are continually improving the companies system to do better!

What do you think? Answer below!

In-Pipe Technology Announces Webinar Series on Municipal Wastewater Fats, Oil and Grease Reduction Using Green Sewer Collection System Treatment

In-Pipe Technology Announces Webinar Series on Municipal Wastewater Fats, Oil and Grease Reduction Using Green Sewer Collection System Treatment











In-Pipe Technology’s G2 Dosing Panel


Wheaton, IL (PRWEB) May 31, 2012

In-Pipe Technology® Company, Inc. announced today a four-week webinar series entitled “Overflow Prevention with Biological Control of Fats, Oil, and Grease” to discuss how In-Pipe’s green sewer collection system treatment is an effective, environmentally-friendly, and fiscally responsible method to prevent fats, oil, and grease (FOG) related wastewater overflows and reduce accumulated FOG deposits.

John Williams, President & CEO of In-Pipe Technology states, “In-Pipe drastically accelerates the natural degradation of FOG in the collection system, thereby removing blockages and occlusions from the pipe and significantly reducing the occurrence of FOG-related sewer overflows, as well as the requisite equipment and manpower required for the physical removal of these blockages. We look forward to sharing our success stories with the municipal wastewater sector.”

The webinar series “Overflow Prevention with Biological Control of Fats, Oil, and Grease” is scheduled to take place as follows:


    June 5th – 11am Central
    June 12th – Noon Central
    June 19th – Noon Central
    June 26th – 2pm Central

For registration information please contact us.

In-Pipe’s patented technology includes regularly adding a high concentration formulation of facultative, naturally-occurring, non-pathogenic bacteria to strategic locations throughout the sewer system in accordance with an engineered plan. This entails zero capital cost and no additional energy requirement. Performance in the collection system provides increased capacity within the plant, forestalls costly upgrades, and extends the life of the existing infrastructure.

In-Pipe Technology offers specialized technical expertise, strong customer understanding, and deep resource knowledge. Since In-Pipe uses natural, biological methods that complement the treatment plant’s own processes, In-Pipe is a sustainable solution ? environmentally and economically.

# # #

If you would like more information about this topic, or to schedule an interview with John Williams, President & CEO, please contact Nikole Clay, Marketing Manager at (630)-871-5844 ext. 229. You may also visit our website at http://www.in-pipe.com.











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, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.









In-Pipe Technology Announces Webinar Series on Municipal Wastewater Lagoon Sludge Reduction Using Green Sewer Collection System Treatment

In-Pipe Technology Announces Webinar Series on Municipal Wastewater Lagoon Sludge Reduction Using Green Sewer Collection System Treatment











In-Pipe Technology’s G2 Dosing Panel


Wheaton, IL (PRWEB) March 29, 2012

In-Pipe Technology® Company, Inc. announced today a five-week webinar series entitled “Lagoon Performance Optimization: An Alternative to Traditional Dredging” to discuss how In-Pipe’s green sewer collection system treatment is an effective, environmentally-friendly, and fiscally responsible method to reduce accumulated lagoon solids.

John Williams, President & CEO of In-Pipe Technology states, “In-Pipe has helped clients reduce accumulated sludge volumes by 40% to 85%, resulting in significant savings every year by extending the intervals between dredging events. Additional benefits are seen in improved BNR, a significant reduction of odors and collection system degradation. We look forward to sharing our success stories with the municipal wastewater sector.”

The webinar series “Lagoon Performance Optimization: An Alternative to Traditional Dredging” is scheduled to take place as follows:

    Central Region: April 17th – Noon Central
    Southwest Region: April 24th – Noon Central
    Northeast Region: May 1st – 11am Central
    Southeast Region: May 8th – 11am Central
    Western Region: May 15th – 2pm Central

For registration information please contact us.

In-Pipe’s patented technology includes regularly adding a high concentration formulation of facultative, naturally-occurring, non-pathogenic bacteria to strategic locations throughout the sewer system in accordance with an engineered plan. This entails zero capital cost and no additional energy requirement. Performance in the collection system provides increased capacity within the plant, forestalls costly upgrades, and extends the life of the existing infrastructure.

In-Pipe Technology offers specialized technical expertise, strong customer understanding, and deep resource knowledge. Since In-Pipe uses natural, biological methods that complement the treatment plant’s own processes, In-Pipe is a sustainable solution ? environmentally and economically.

If you would like more information about this topic, or to schedule an interview with John Williams, President & CEO, please contact Nikole Clay, Marketing Manager at (630)-871-5844 ext. 229. You may also visit our website at http://www.in-pipe.com.









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Vocus©Copyright 1997-

, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.







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In-Pipe Technology Awarded Contract for Green Sewer Collection System Treatment in Huntington, NY

In-Pipe Technology Awarded Contract for Green Sewer Collection System Treatment in Huntington, NY











In-Pipe Technology’s G2 Dosing Panel


Wheaton, IL (PRWEB) March 27, 2012

In-Pipe Technology® Company, Inc. announced today the Town of Huntington, NY awarded a contract for In-Pipe to provide professional, green sewer collection system services to the wastewater treatment plant’s collection system to improve treatment efficiency and reduce energy and sludge processing costs at the plant. In-Pipe’s services will also improve Huntington’s nitrogen removal capability assisting the Town with meeting the future low nitrogen discharge limits. The Huntington treatment plant discharges to the Long Island Sound, and therefore must meet very low nitrogen limits in the near future.

This collaborative project will also be supported by Wendel Energy Services, which will work with In Pipe to maximize digester gas production and potentially provide a Combined Heat & Power (CHP) operation to significantly reduce Huntington’s power consumption from the grid. Additional goals of the project include increased rated capacity for treatment and fats, oils, and grease (FOG) elimination,

”We look forward to working with In-Pipe on this multifaceted project”, stated Neal Sheehan, Huntington’s Director of Environmental Waste Management. “Our major challenge is our future nitrogen limits, and In-Pipe appears to be able to provide a wide spectrum of tangible economic benefits in addition to reducing our nitrogen discharge loading.” John Williams, President & CEO of In-Pipe Technology added, “We look forward to working with the Huntington team. Everyone involved in the project is deeply committed to environmental stewardship.”

In-Pipe’s patented technology includes regularly adding a high concentration formulation of facultative, naturally-occurring, non-pathogenic bacteria to strategic locations throughout the sewer system in accordance with an engineered plan. This entails zero capital cost and no additional energy requirement. Performance in the collection system provides increased capacity within the plant, forestalls costly upgrades, and extends the life of the existing infrastructure.

In-Pipe Technology offers specialized technical expertise, strong customer understanding, and deep resource knowledge. Since In-Pipe uses natural, biological methods that complement the treatment plant’s own processes, In-Pipe is a sustainable solution ? environmentally and economically.

If you would like more information about this topic, or to schedule an interview with John Williams, President & CEO, please contact Nikole Clay, Marketing Manager at (630)-871-5844 ext. 229. You may also visit our website at http://www.in-pipe.com.









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Vocus©Copyright 1997-

, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.







Tsunami Multi-Channel Warning System Enters Field Testing

Tsunami Multi-Channel Warning System Enters Field Testing











London, UK (PRWEB) January 17, 2012

eVigilo will integrate its Alert and Distribution Center (IADC) with the Global Disaster Alert and Coordination System (GDACS). IADC will receive Tsunami notifications from GDACS or from National authorities (e.g. Civil Protection) and will send automatically geo-targeted Internet and mobile alert messages across multiple channels such as : Push IP over fix and mobile networks, cell broadcast as well as TV, radio, sirens, billboards and pagers.

By using various channels to reach people at risk, the integration of the two systems will help maximize the number of people that can be directly alerted in case of a Tsunami. Thorough testing of the joint-system will be executed in Setubal (Portugal), 50km south of Lisbon, in collaboration with the local Civil Protection authorities and the local municipality, who have already developed a detailed evacuation plan in case of flooding due to a potential Tsunami.

eVigilo CEO Guy Weiss has said: “We are thrilled to become proactive members in this joint research project and happy to contribute from our knowledge. We are confident that our practical experience in designing national Tsunami alert and notification systems will contribute to this project and will serve as model for other countries.”

Through the Global Disaster Alert and Coordination System (GDACS), the JRC will provide scenario calculations and Tsunami analyses. In the event of an incoming tsunami wave, innovative software automatically calculates the results of tsunami propagation predictions and alerts via SMS or email the international responder community. GDACS could also directly alert people at risk by activating alerting devices such as the Tsunami Alerting Device’s (TAD). Alternatively the activation of the alerting devices could be decided by the local National authorities that then in turn would dispatch an alerting message through various channels, including TV, radio and devices such the TAD with one single command.

As part of the concept, eVigilo will enable the authorities to maintain interactive communication with the population through dedicated Smartphone applications. Those applications will enable the population to respond to messages received and send “Panic Messages” to the authorities when they are in distress. The authorities will be able to geo-locate those messages on a map using eVigilo IADC and execute required rescue efforts.

About eVigilo

eVigilo designs and develops the industry’s only fully-integrated mass alert platform that can reach millions of people in just seconds, to substantially improve personal safety and save lives. Supporting communication between multiple alert channels, eVigilo line of products are both holistic and flexible alert platforms. Thus, eVigilo provides the most effective and efficient turnkey solution for mass alert systems, used by governments, homeland security agencies, municipalities and industrial organizations. For more information please visit http://www.evigilo.net

About the JRC

The Joint Research Centre (JRC) is the European Commission’s in-house science service.

Its mission is to provide customer-driven scientific and technical support for the conception,

development, implementation and monitoring of European Union policies. The JRC serves

the common interest of the Member States, while being independent of special interests,

whether private or national. Through its Institute for the Protection and Security of the Citizen (IPSC) the JRC develops methods and technologies in support to crisis management operations.

For further information please visit http://www.jrc.ec.europa.eu


About GDACS

The Global Disaster Alert and Coordination System (GDACS), jointly developed by the JRC and the United Nations, is a web-based platform that sends an automatic email or SMS message to its users worldwide and instantly alerts them in case of disasters that require international humanitarian intervention. GDACS aims at consolidating and strengthening the network of providers and users of disaster information worldwide in order to provide reliable and accurate alerts and impact estimations after sudden-onset disasters and to improve the cooperation of international responders in the immediate aftermath of major natural, technological and environmental disasters.

For further information, please visit http://www.gdacs.org

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Vocus©Copyright 1997-

, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.







Changing the Economic System (3/7) Robin Hahnel

Econvergence Conference: NW Regional Gathering on the Economic & Ecological Crises Portland, Oregon ** October 2-4, 2009 This workshop was titled “Changing the Economic System: Why We Must & How We Can” and was given on October 2, 2009 (I lost the recording of the Q & A, sorry) In this session, panelists point out the limits of proposed reforms to capitalism such as green capitalism, alternative energy, local production, fair trade & a welfare state. They will also show the weaknesses of the current reforms to the economic crisis. Robin Hahnel and Peter Bohmer will discuss the principles of a participatory economy & strategies to achieve it. They will talk about the relation between reformist and revolutionary change. Cindy Milstein will examine the successes and limitations of applying participatory economic principles within a larger capitalist society. Adam Sanchez will talk about how democratic socialism is necessary to overcome the economic and environmental crises. Adam Sanchez – International Socialist Organization Robin Hahnel – Professor Emeritus of Economics, American University and Professor of Economics, Lewis & Clark College & Portland State University Cindy Milstein – Institute for Anarchist Studies Peter Bohmer – Professor of Political Economy, The Evergreen State College
Video Rating: 5 / 5

Doha 2010 – Renovating the International System

www.weforum.org 30.05.2010 When states were the overwhelmingly dominant actors on the world stage and major policy decisions were commonly decided by a limited group of them, progress on international cooperation tended to be measured by the establishment of new intergovernmental legal frameworks and institutions. In a more complex and interdependent world, how can other potential dimensions of cooperation be more fully exploited, including practical, results-oriented coalitions, better information systems, strengthened existing institutions and more systematic integration of non-governmental expertise and resources? Ahn Ho-Young, Deputy Minister of Foreign Affairs and Trade of the Republic of Korea; Ambassador at Large for G20 Alexandre Fasel, Ambassador, Federal Department of Foreign Affairs, Switzerland He Yafei, Ambassador and Permanent Representative of the People’s Republic of China to the United Nations, Geneva Richard Samans, Managing Director, World Economic Forum Chaired by Lord Malloch-Brown, Vice-Chairman, World Economic Forum

Friedrich Hayeks lecture on Evolution & Spontaneous order at the 1983 – 33rd Meeting of Nobel Laureates at Lindau. We know that Charles Darwin’s theory of evolution is accepted by natural scientists. It describes how biological systems spontaneously evolve by the mechanism of natural selection. But is a similar spontaneous evolution taking place in areas of social construction and cultural behaviour? Friedrich von Hayek argues that this is the case. He underlines the complexity of the social systems and gives an historic overview reaching all the way back to Aristotle. As well as comparing and contrasting the mechanisms of natural and social evolution, and outlining the role of social evolution in the development and maintenance of civilisation.
Video Rating: 5 / 5

Environmental Management System Review-ISO 14001 Gap Analysis Protocol Audit Checklist

ISO 14001 really are a generic document and it doesn’t specify “how” to complete, but only states “what” to complete. As per the standard, environmental surroundings Management System should be documented and be demonstrable in the way in conjuction with the requirements of ISO 14001 models. The total demonstration in the Environment Management System includes four tiers of documents.

1.Environment Manual
2.Procedure Manual
3.Work Instruction/Operating Procedure Manual
4.Forms, Records

The amount of documentation should support and efficient Environment assurance system without creating a paper bureaucracy. The facts for documenting above four tiers of documents is described within this paper.

NEED FOR DOCUMENT CONTROL:

Environmental surroundings System consists of a number of documents. Some system ought to be provided for safe keeping of complex records. It is important to clearly define as to where they should be kept and for just how long, and who’s accountable for them. Each written procedure should be checked and signed by an authorized person, with issue number and issue date. The management representative must have a summary of all completed procedures, applicable to the individual departmental activities. Against each listed document the amount should be shown with the date from the latest change. It is also known as a “Master Copy”. It’s a yardstick against which any other controlled copy can be judged.

Every once in awhile the Committee for Management Review and Corrective Action may submit recommendations for change in the process. The Management Representative should be responsible for implementing the change. For making a big change, the new page ought to be circulated towards the keeper from the controlled copy of the document by having an instruction to insert the brand new page in order and return the replaced page to the Management Representative. Thus outdated documents is going to be removed from circulation. The change, that has been made, ought to be recognized to the staff and everybody should implement the new procedure. Whenever a number of major changes happen to be made, a complete new manual needs to be issued. The retention period for these records could be predefined either contractually or through the policy and it is to be mentioned in the Environment Manual.

Now, let’s talk about Environmental Management System from Graham A. Browri & Associates and how it may assist you. I hope this simple Environmental Management System Review will assist you to differentiate whether Environmental Management System is Scam or perhaps a Genuine.

Here’s your opportunity to download an Environmental Management System Audit Checklist template with 254 inquiries to assist you to conduct efficient internal EMS auditing programs needed by the ISO 14001:2004 standard. Our EMS audit tool can also be flexible enough that will help you audit a whole organization or system, or simply a particular a part of an organization (unit, site, operational area, team, activity, etc). Follow our well worn steps to EMS auditing today. We now have done all of the effort for you personally. Just download the MS Word documents to get started today.

If you are still wondering, you might want to check out Environmental Management System Review to explore the product in addition to Graham A. Browri & Associates reputation. Find all the answers on my review site now!

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OSHA to Adopt the Globally Harmonized System for Classification and Labeling of Chemicals

OSHA to Adopt the Globally Harmonized System for Classification and Labeling of Chemicals











Cary, NC (PRWEB) April 13, 2011

Do you know what this symbol means? Every worker in the US will need to know it, as well as others that OSHA is adopting this year.

The Occupational Safety and Health Administration has announced that by August of this year, companies in the US must begin to adopt the globally harmonized system (GHS) for the classification and labeling of hazardous chemicals. This means that virtually every product label, material safety data sheet (soon to be called “safety data sheet”), and written hazard communication plan must be revised to meet the new standard. Worker training must be updated so that workers can recognize and understand the symbols and pictograms on the new labels as well as the new hazard statements and precautions on MSDSs.

Environmental Resource Center is offering a 1-hour webcast to help companies learn how the new rule that OSHA is adopting differs from current requirements, how to implement the changes, and when the changes must be implemented.

The $ 99 webcast will be conducted from 2:00 pm to 3:00 pm ET on the following dates:

May 2nd

May 16th

June 2nd

June 17th

The first three webcasts held in April of this year were completely sold out. Register early to ensure your spot. Click here to register online or call 800-537-2372 to register by phone.

Environmental Resource Center, Inc. is a leading environmental, health, and safety training and consulting firm. Since 1981, the company has provided environmental, safety, health, and transportation training for the nations’s foremost companies, government agencies, universities, and hospitals.

For additional information on Environmental Resource Center or this press release, visit http://www.ercweb.com, or call 800-537-2372 x 227.

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Vocus©Copyright 1997-

, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.







How could some of these things make a change in a good way in our economic system in the U.S?

Question by nwofu: How could some of these things make a change in a good way in our economic system in the U.S?
The ultimate driver of all economies, internalizing the external costs, using economics/laws/regulations to increase environmental quality, full cost pricing, trading pollution, green taxes, user fees, and earth-sustaining economies.

Best answer:

Answer by warnick69
I ON,T THINK THERE IS A SIMPLE ANSWER TO YOUR QUESTION AS THEY HVE YET TO BE WORDED OUT —
Pure free-market economies don’t exist because they have flaws that require government intervention in the marketplace. This can prevent a single seller or buyer (monopoly) or a single group of sellers or buyers (oligopoly or cartel) from dominating the market and thus controlling supply or demand and price. Governments intervene in economies to…. ·provide national security, education, and public goods ·help redistribute some income and wealth ·protect people from fraud, trespass, theft, and bodily harm ·protect the health and safety of workers and consumers ·help ensure economic stability Pure command economies don’t exist either. Countries in Eastern Europe, the former Soviet Union, and China have moved away from command economic systems and toward market-based approaches.Economic Growth and External Costs How is economic growth measured? Economic growth- an increase in the capacity of the economy to provide goods and services for people’s final use. Such growth is usually accomplished by maximizing the flow of matter and energy resources (throughout) by means of population growth (more consumers), more consumption per person, or both

Add your own answer in the comments!