Learn Microsoft Excel by Mike Thomas

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If you are into preparing reports and summaries, then knowing how to create Pivot Tables is one of the must have skills that will help you to get your job done quickly. This advanced training will be provided using Excel 2016 for Windows. You will get a tangible foundation to build your own pivot tables and reports.

A Quick glance of this webinar:

To attend this training you don’t have to be proficient in using Excel. If you can create basic worksheets, understand simple formulas, copy and paste and apply basic formatting to cells, then you’ll be able to follow this training easily.

Session Highlights:

  • Creating a Pivot Table
  • How to use Slicers and Timelines to interactively filter your data?
  • Sorting and grouping the Pivot Table data and more…

 Why Should You Attend:

You should attend this webinar if you need to use Excel to quickly build reports and summaries or if you simply want to learn how to create Pivot Tables to improve your knowledge of Excel.

You don’t have to be proficient in the use of Excel to attend. As long as you can create basic worksheets, understand simple formulas and can copy and paste and apply basic formatting to cells, you’ll be able to follow along.

The training will be delivered using Excel 2016 for Windows. However, much of the functionality is available in Excel 2013 and 2010 and 2016 for Mac.

About the Speaker:

Mike Thomas is no new to training. He has been working in the IT training business since 1989. He specializes in drafting and presenting training courses, writing training materials and recording and editing video-based tutorials. He is the subject matter expert in wide array of Microsoft technologies especially Excel. Mike also designs and develops Microsoft Office-based solutions that help in automating vital business tasks and processes.

About Compliance Global:

Based in New Hyde Park, New York, we at Compliance Global Inc. offer training solutions to all sized businesses. We are known for providing quality webinar trainings at competitive prices. Our speakers are highly established industry experts, top consultants, and renowned subject matter experts. Visit www.complianceglobal.us

For more detail please click on this below link:

http://bit.ly/2ley3mL

Email: referrals@complianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

 

Fax: +1-516-900-5510

Controlling human error in the manufacturing floor

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Overview:

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This Human Error Prevention & Reduction webinar offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Why Should You Attend:

This training will provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes and root causes for these events. Also, we will discuss latest trends in human error issues in the industry.

Areas Covered in this Webinar:

Background on Human Error Phenomena
Importance of Human Error Prevention/reduction
Training and human error
Facts about human error
Human Error as the Root Cause
What is Human Error
How is Human Error controlled?
Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
Types of error
Human error rates and measurement
Trending and tracking
Prediction
CAPA effectiveness

Learning Objectives:

Understand human error: factors and causes.
Understand the importance: regulatory and business.
Define the process to manage Human Error deviations.
Identify Root Causes associated to human error deviations.
Learn how to measure human error rates at your site.
Identify what I can do to support human reliability.

Who Will Benefit:

Training managers and coordinators
Operations
Manufacturing
Plant engineering
QA/QC staff
Process excellence/improvement professionals
Industrial/process engineers
Compliance officers
Regulatory/legislative affairs professionals
General/corporate counsel

Speaker Profile:

Ginette Collazo, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas.

She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others.

Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies.

For more detail please click on this below link:

http://bit.ly/2oBgCzj

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Understanding FDA Auditing Practices

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Speaker: Kenneth Christie
Date: May Tuesday 16th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 90 Minutes
Product Code: 700709
Level: Intermediate

 

Overview:

The success of getting through any audit by federal regulators and third party auditors is not only dependent on a well prepared training of all staff and department employees, but also in knowing what the focus has been of recent inspections within the industry. Such information provides a template for companies to look closely at their own practices in helping to assure similar findings are adequately addressed. In addition, as the audit techniques of the FDA have changed over the years, knowing what to expect can help establish a focused training program as part of the preparation.

This FDA GMP compliance webinar is considered to provide a basic level of information relative to FDA auditing practices and expectations. It will also help companies to understand the most common areas of deficiencies as they apply to drug manufacturers.

Why Should You Attend:

This webinar will look as changes in the FDA’s approach to audits and the current method used by the agency to determine audit frequencies by using a system of “risk assessments”. The top 10 most cited GMP deficiencies for drug manufacturers for the last year (2015-2016) will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Knowing how best to address 483 observations is also part of successfully avoiding potential warning letters. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentation.

Areas Covered in this Webinar:

Changes in FDA audit approaches

Most common cited GMP drug deficiencies for 2015-2016

Increase in FDA enforcement actions

How best to address FDA 483 observations when received.

Learning Objectives:

This webinar will provide the attendees with a better understanding of the current audit techniques used by the FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues and how best to address 483 observations given upon completion of an audit. Additionally, the webinar will provide an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited drug manufacturing GMP deficiencies over the last several years.

Who Will Benefit:

Quality Assurance

Quality Control

Manufacturing

Production

Regulatory

Laboratory Personnel

Management

Equipment vendors

Speaker Profile:

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries.

Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

For more detail please click on this below link:

http://bit.ly/2oBcWxj

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Cosmetic Testing for US FDA Compliance

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Speaker: Rachelle D’Souza
Date: May Thursday 11th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Product Code: 700715
Level: Intermediate

 

Overview:

The US Food and Drug Administration (FDA) hold cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such as color additive manufacturers and analytical and microbiological laboratories on FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Topic areas covered in this webinar include, FDA considerations for microbiological testing, animal testing, potential contaminants, nanomaterials in cosmetics, cosmetic good manufacturing practices (GMP) compliance testing, shelf life/expiration dating, select cosmetic ingredients and color additive batch certification.

Why Should You Attend:

FDA periodically analyzes cosmetics, especially if aware of a potential problem. The information obtained can be used to alert consumers, support regulatory actions. To avoid action from the regulatory body. Cosmetic manufacturing companies should test the cosmetic product before it start selling the product. Attend this cosmetic safety training to learn different types of cosmetic testing which are practiced in the cosmetic industry to achieve compliance with the US FDA.

Areas Covered in this Webinar:

Microbiological Testing for cosmetics
Animal Testing & Cosmetics
Potential Contaminants
Color Additives & Batch Certification
Select Cosmetic Ingredients: Prohibited & Restricted Ingredients
Shelf Life/Expiration Dating
Nanomaterials in Cosmetics
Cosmetic Good Manufacturing Practices (GMP) Compliance Testing

Learning Objectives:

To ensure safety and quality of a cosmetic/cosmetic ingredient and achieve compliance with the US FDA

Who Will Benefit:

Cosmetic Manufacturers
Cosmetic Distributors
Cosmetic Ingredient Manufacturers
Color Additive Manufacturers
Analytical & Microbiological Laboratories involved in Cosmetic / Cosmetic Ingredient Testing

Speaker Profile:

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

For more detail please click on this below link:

http://bit.ly/2ptYqLN

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Proper Management of Regulatory Inspections

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Speaker: Danielle DeLucy
Date: May Thursday 11th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Product Code: 700710
Level: Beginner 

 

Overview:

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This webinar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.

Why Should You Attend:

To learn the how to set up support groups/rooms for the inspection.

Learn how to properly communicate with the inspector.

To be able to organize requests from the inspectors and process them in a timely and accurate manner.

Know what is expected of you and your company.

Learn what not to say or do during an inspection.

To learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection.

Areas Covered in this Webinar:

Pre-planning and preparation activities
What to do when the investigator arrives
What documents to have ready and on hand
Assignments and responsibilities for the inspection
A review of Inspection Do’s and Don’ts
The Opening and Close-out Sessions

Learning Objectives:

Upon completion of this session, attendees will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.

Who Will Benefit:

Site Quality Operations Managers

Quality Assurance personnel

Plant Managers and Supervisors

Manufacturing Superintendents and Managers

Individuals whose job knowledge and/or expertise may be called upon during an audit

Regulatory Affairs Managers

Speaker Profile:

Danielle DeLucy, MS, is an Independent Consultant to the Biologics and Pharmaceutical Industries.

Danielle DeLucy, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.

Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

For more detail please click on this below link:

http://bit.ly/2ooxA31

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Environmental Monitoring – Knowing your cleanroom

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57881e91898e0Speaker: Carl Patterson
Date: May Thursday 11th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 90 Minutes
Product Code: 700717
Level: Intermediate

 

Overview:

This webinar will provide the proper methods and techniques required to maintain a clean room per FDA and ISO regulations. By the use of viable and non-viable testing, a cleanroom can be maintained. The results collected can determine the state of control the cleanroom operates on a continuous basis.

Why Should You Attend:

Personnel involved with monitoring, trending, and drawing conclusions from the testing related to environmental monitoring. Personnel who are uncertain their current environmental monitoring program is effective and/or meets current FDA and ISO regulations. Personnel who need to understand what controls are in place in order to maintain a state of control to their cleanroom(s).

Areas Covered in this Webinar:

Environmental monitoring is the process of testing cleanrooms to ensure these rooms maintain a state of control. Non-viable testing is testing done to monitor the amount of total particulates within a cleanroom. Viable testing is categorized into air and surface monitoring. The viable air monitoring can be further divided into passive monitoring and active monitoring. Cleaning agents are used to lower the amount of viables within a room and increased usage can be done during contamination events.

Learning Objectives:

The most appropriate cleaning agents and possible schedules for use of the cleaning agents
Trending methods in order to ensure the cleanroom is maintaining a state of control
How a cleanroom can be maintained to perform in accordance with ISO and FDA regulations

Who Will Benefit:

Pharmaceutical Manufacturing Companies
Contract Manufacturing Companies (CMOs)
Personnel involved with Environmental Monitoring Operations

Speaker Profile:

Carl Patterson, M.S. has completed twelve (13) plus years in the biotechnology, pharmaceutical manufacturing, and quality fields. He completed his Bachelor’s of Science in Microbiology from the University of Texas.

Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master’s of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and environmental monitoring. He has helped to insure the expectations, related to aseptic processing and environmental monitoring, have been met.

For more detail please click on this below link:

http://bit.ly/2ojhvfQ

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Moving from an Operational Manager to a Strategic Leader

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prefix_Chris DeVanySpeaker: Chris DeVany
Date: May Thursday 11th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 90 Minutes
Product Code: 700720
Level: Advanced

Overview:

Gain the insights and skills to know where your business stands today and where it’s heading tomorrow.

In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for:

Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs and expectations
Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs’ flexibility and responsiveness
Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department’s value to the organization
Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!
If you want to move from being a good manager to being a great manager, you can’t afford to miss this project management training. Because strategic leadership is a blending of attributes that every superior manager requires in today’s unpredictable business environment.

Here’s where you’ll learn to anticipate, initiate and manage change for maximum competitiveness, stay on course while constantly redefining and refocusing your department’s goals in order to hit a moving target and determine where your unit is headed, as you take into account the multiple groups your decisions will impact.

Prepare to make a transition. Instead of being buried in your department’s ongoing activities, you’ll become an innovator able to add value to your organization, its customers and stakeholders. This course will provide you with the skills required to move your team or department forward decisively.

Why Should You Attend:

By attending, you will be able to more effectively:

Inspire and direct your team to greater readiness and competitiveness
Add value to your organization by understanding the needs of your customers
Anticipate, create and encourage change
Spot opportunities for successful strategic alliances
Become an innovative, visionary leader
Establish a strategic culture
Identify the strengths and weaknesses in your work unit
Keep your unit moving forward
Take risks with confidence
Would you like to inspire and direct your team more effectively?

What about being more able to anticipate, create and encourage change?

How about becoming an innovative, visionary leader?

Would you like your team to improve performance?

If you answered “yes” to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, key questions and answers we all need to be able to address effectively to improve our team members’ and team’s performance!

Areas Covered in this Webinar:

What We Will Address

Crossing the line to strategic effectiveness
Learning the strategic leadership approach
Vision and strategic leadership
Becoming an effective leader
Building influence through communication
Understanding the role of teams
Managing change with action-oriented skills

Learning Objectives:

What We Will Address

Crossing the line to strategic effectiveness
Learning the strategic leadership approach
Vision and strategic leadership
Becoming an effective leader
Building influence through communication
Understanding the role of teams
Managing change with action-oriented skills

Who Will Benefit:

CEO
Executives
Senior Managers
Managers

Speaker Profile:

Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include such organizations as Microsoft, Visa International, the Society for Human Resource Management (SHRM), U.S. Department of Housing and Urban Development, Sprint, American Counseling Association, Aviva Insurance, U.S. Patent and Trademark Office, Big Brothers and Big Sisters, Hospital Corporation of America, Schlumberger, Morgan Stanley, Boston Scientific, US HealthCare and over 500 other organizations in 22 countries.

For more detail please click on this below link:

http://bit.ly/2ojaVWJ

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Know the quickest and best ways to create Pivot Tables and Pivot Charts

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Using a PivotTable, you can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques. The PivotTable feature is perhaps Excel’s best analytical tool and in addition to its speed, you get amazing flexibility and dynamism that let you quickly change the data interrelationships you’re viewing. Most PivotTable users discover that the feature is relatively easy to learn, but not so easy if you are simply seeing the instructions on the printed page; this is a visually-oriented feature based on displaying fields in different locations.

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there’s no better feature than a Pivot-Table. You’ll be amazed to see how, in very little time, you can create a complete summary report with tons of data and you won’t even need to write formulas and rely on obscure techniques.

If you need to analyze all the Excel data and do it quickly, then join us for this interactive session.

Course Description:
This course will enable you to cover the quickest and best ways to create PivotTables and Pivot Charts.

  • How to compare two or more fields in a variety of layout styles
  • How to sort and filter results
  • How to perform ad-hoc grouping of information
  • How to use Slicers instead of filters to identify which field elements are displayed
  • How to categorize date/time data in multiple levels
  • How to create a Pivot Chart that is in sync with a PivotTable
  • How to add calculated fields to perform additional analysis
  • How to create a PivotTable based on data from multiple worksheets

Instructor Dennis Taylor has taught thousands of Excel seminars and classes since the early 90’s, is the author/presenter of over 500 Excel webinars, and authored the book Teach Yourself Microsoft Excel 2000.

About Compliance Global:

Based in New Hyde Park, New York, we at Compliance Global Inc. offer training solutions to all sized businesses. We are known for providing quality webinar trainings at competitive prices. Our speakers are highly established industry experts, top consultants, and renowned subject matter experts. Visit www.complianceglobal.us

Source link: http://bit.ly/2otLaTb

New final rules and guidance by HUD

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HUD has just issued new final rules and guidance on final rules which affect fair housing protections. During the live session, the speaker will explain in detail how these updates should be implemented in today’s fair housing environment.

A Quick glance of this webinar:

HUD’s 102-page Final Rule requires that the Notice of Occupancy Rights and accompanying certification form be provided. Attend this webinar and gain thorough understanding.

Session Highlights:

  • How does this affect landlord liability?
  • Do I have to change policies?
  • When are rules effective? And more…

Why Should You Attend:

HUD’s Final Rule implementing the Violence Against Women Reauthorization Act (VAWA) of 2013 was published in the Federal Register on November 16, 2016. This Final Rule details the requirements for the HUD-covered programs and is effective Dec. 16, 2016. It is important to note that VAWA 2013 also covers the LIHTC and Rural Housing programs, but the Departments of Treasury and Agriculture have not issued their Final Rule for these programs to date. Many state agencies, however, have already incorporated VAWA 2013 compliance into their state requirements.

Learning Objectives:

HUD’s 102-page Final Rule requires that the Notice of Occupancy Rights and accompanying certification form be provided at the following times:

  • At admission to a covered program;
  • At rejection from a covered program;
  • Within one year for all existing residents; and,
  • At time of notification of termination of tenancy or termination of assistance for all current residents.

About the Speaker:

Speaker Paul Flogstad has over 38 years of experience in the real estate industry including sales, construction, project management, appraisal, property management, consulting, and training. He owns a consulting company Property Management Solutions, which provides training and consulting services nationwide to owners, management companies, multi-housing associations, and federal agencies. In 2009, he received the Outstanding Educator of the Year award from the South Dakota Multi-Housing Association.

About Compliance Global:

Based in New Hyde Park, New York, we at Compliance Global Inc. offer training solutions to all sized businesses. We are known for providing quality webinar trainings at competitive prices. Our speakers are highly established industry experts, top consultants, and renowned subject matter experts. Visit www.complianceglobal.us

Source link: http://bit.ly/2mGswpW

How to ensure accuracy of info on the Form 1099?

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This webinar is a must for persons who send, receive, and review W-9 forms. The speaker will not only cover the new filing dates but also explain line by line the W-9 information and how it affects the Forms 1099.

A Quick glance of this webinar:

During the live session, attendees will get to know the steps and tips that lead to the accuracy of information on the Form 1099.

Session Highlights:

  • Most common mistakes on W-9 and 1099
  • Why using IRS TIN matching is important
  • Tips for avoiding IRS Notices and Penalties and more…

Why Should You Attend:

This webinar is a necessity for persons who send, receive, and review W-9 forms.  We will be covering not only the new filing dates but line by line W-9 information and how it effects the Forms 1099.  If your company wants to avoid IRS Form 1099 notices and potential IRS Form 1099 Penalties, this course is a must.

Areas Covered in this Webinar:

  • New 2017 Form 1099 due dates
  • Line by line completion of Form W-9
  • Why review of completed W-9 Forms is important
  • Most common mistakes on W-9 and 1099
  • Matching names and TINs against IRS TIN matching program
  • Why using IRS TIN matching is important.
  • Tips for avoiding IRS Notices and Penalties

About the Speaker:

Speaker Greta P. Hicks is a former IRS Revenue Agent and Regional Training Coordinator. Greta has her own business now and for over 34 years her CPA practice has been limited to representing persons who have IRS problems.  She has authored several continuing education courses on IRS practice & procedures and has taught Tax Update Seminars as well as various Inside the IRS topics.

About Compliance Global:

Based in New Hyde Park, New York, we at Compliance Global Inc. offer training solutions to all sized businesses. We are known for providing quality webinar trainings at competitive prices. Our speakers are highly established industry experts, top consultants, and renowned subject matter experts. Visit www.complianceglobal.us

Source link: http://bit.ly/2mjlbBc

Risk Based Thinking in and Beyond ISO 9001:2015

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Speaker: William A. Levinsondownload
Date: May Wednesday 10th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Product Code: 700690
Level: Intermediate 

Overview:

ISO 9001:2015’s new clause for “actions to address risks and opportunities” is among the biggest revisions to the standard. Risks and opportunities that relate to waste or muda, and also to changes in technology, markets, and distribution channels are however not explicitly covered, and are therefore not explicitly auditable, even under the new standard.

This credit risk mitigation presentation will therefore focus on use of the standard as a servant whose purpose is to promote the organization’s competitiveness and profitability, rather than a master whose requirements the organization has to satisfy to get the ISO certificate. ISO 9001 becomes the servant when the organization uses it as a framework to drive continual improvement and to identify risks and opportunities that lie well beyond the scope of the standard.

Why Should You Attend:

ISO 9001:2015 requires “actions to address risks and opportunities” (clause 6.1) with regard to (1) the context of the organization (clause 4.1) and needs and expectations of interested parties (clause 4.2). The failure of Kodak’s world-class and ISO 9001 registered photographic film division shows, however, that mere conformance to the standard is not adequate to ensure profitability or even survival.

The standard also has no explicit requirement to address any of the Toyota production system’s Seven Wastes, except of course for poor quality. The other six wastes (muda) can however be far more costly than poor quality. They are also asymptomatic (without symptoms) so, unlike poor quality, they rarely announce their presence. The organization must seek them out systematically to achieve optimum results. The good news is that, once the organization has identified the waste, it is relatively easy to adapt existing corrective and preventive action (CAPA) processes to remove it.

Areas Covered in this Webinar:

ISO 9001:2015 tells us what we must do with regard to “actions to address risks and opportunities.” The scope of this clause includes the context of the organization, and needs and expectations of interested parties. This presentation will however focus not on what we have to do to meet the standard’s basic requirements, but on what we ought to do to achieve sustained world-class performance.

ISO 9001 originated from a military specification for quality assurance requirements, and it has focused historically on quality. The scope of risks and opportunities includes, however, not only quality (only one of the TPS Seven Wastes) but also waste or muda, supply chain risks, and external risks and opportunities from new technology and new product distribution channels. As an example of the latter, the countries that controlled the western end of the Silk Road in the 15th century had a great moneymaking monopoly on trade from the Far East—until Vasco da Gama ruined their day by circumnavigating Africa. The Internet is doing something similar to many brick and mortar enterprises today. The digital photography that Kodak helped invent rendered the company’s world class photographic film almost entirely obsolete.

General Carl von Clausewitz’s term “friction” meanwhile applies squarely to many forms of internally controllable waste or muda. Friction means simply everyday annoyances that force people to correct or work around seemingly minor problems, but ultimately degrade the organization’s performance. Awareness of friction is a prerequisite for its removal.

Risk is meanwhile the consequences of an undesirable occurrence times its probability. Probability (or frequency) involves, however, not just the chance of an individual occurrence—the focus of the occurrence rating in failure mode effects analysis (FMEA)—but also the frequency of exposure to the risk. The concept that risk = np rather than just p, where p is the chance of an individual occurrence and n the number of exposures, leads in turn to the principle that only engineering controls (error-proofing, poka-yoke) countermeasures can ensure that the problem never occurs. The Army’s Risk Management process makes it clear that engineering controls are superior to administrative controls that rely on worker vigilance for effectiveness.

The supply chain is an enormous source of risk because interruption of purchased goods will render even the leanest and best-quality factory unable to produce anything. A reliable supply chain is, in fact, a prerequisite for just in time control systems that carry little or no protective inventory. Henry Ford, whose logistics system was compared to a “continent-spanning conveyor” (Norwood, 1931. Ford: Men and Methods), pointed this out explicitly in My Life and Work (1922).

Organizations can also create their own risks as shown by Mylan’s price hikes on its Epi-Pen epinephrine injector. It was only a matter of time until competitors stepped in to offer generic alternatives.

Learning Objectives:

ISO 9001 originated to address quality risks in complex organizations with handoffs between processes over which no individual person had total control.
ISO 9001 has focused heavily on risks associated with poor quality, but not on other forms of waste or muda that can easily be far more costly than poor quality. Poor quality makes its presence known very quickly if it is not prevented, and it often is, by planning for quality through, for example, FMEA.
“Risk = np and not just p.” This principle is straight from the Army’s Risk Management Process, which recognizes that risk is not just the chance of an individual occurrence (p), but also the number of times (n) we are exposed to it. This requires engineering controls, error-proofing, or poka-yoke to make the undesirable occurrence impossible (p=0) because, if p>0, the problem will eventually occur if we are exposed to the risk enough times. (The application here is primarily to quality and safety.)
The Army’s Risk Management Process is a free (public domain, publication of the U.S. Government) off the shelf resource on risk management. It encompasses most if not all the provisions of ISO 31000:2009.
It is vital to address supply chain risks, as well as risks associated with changing technology and distribution channels, regardless of whether ISO 9001:2015 requires explicit consideration of these matters. (Clause 4.1 could however be construed in this manner, as it requires the organization to consider “internal and external issues” that could affect its ability to “achieve the intended result(s) of its quality management system.”)
The Epi-Pen controversy underscores the risks associated with raising prices to the point where competitors will step in to follow the advice of the Mob Museum in Las Vegas: “Give the people what they want.” Changes of this nature often encourage or even compel innovation by competitors and other stakeholders.

Who Will Benefit:

All management, noting that ISO 9001:2015 is explicitly the responsibility of the management team rather than a management representative. Quality and manufacturing engineers and technicians also may benefit from some of the principles for identifying risks and opportunities.

Speaker Profile:

William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt.

He is also the author of several books on quality, productivity, and management, of which the most recent is The Expanded and Annotated My Life and Work: Henry Ford’s Universal Code for World-Class Success.

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