Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.

So, what is medical device hazard analysis? Medical device hazard analysis may be defined as a structured method of analyzing the inherent and potential problems that a medical device could have at any stage of its production or after it is released into the market.

The need for medical device hazard analysis

Medical device hazard analysis has to be done for a number of reasons. It is required by the FDA as part of a product development Design Control Program. The FDA recommends ISO 14971 as the standard for medical device hazard analysis. This is because the ISO 14971 hazard analysis standard is considered the most comprehensive of all medical device hazard analysis tools.

What makes this so is that the ISO 14971 takes risk into consideration in normal state, as opposed to other tools such as Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA), which only consider fault conditions. The latter two, in relation to the ISO 14971 standard, are more suitable for as tools for reliability rather than as those for product safety.

However, despite the uses it has; medical device hazard analysis in relation to ISO 14971 is considered quite complex because of the free and broad implication of a few important terms, even if they are pretty straightforward in terms of their definitions. Some of the words that cause confusion over their interpretation when they are being put to practical use include:

Hazard: Generally described as the potential site or basis of harm

Hazardous situation: A circumstance or situation which exposes people to a hazardous event or environment

Harm: Any degree of physical damage or injury from the medical device to the people working with it, or to the property or to the environment

Causative event: An event that may be said to be the source or cause of an adverse event in a medical device

ALARP: As Low as Reasonably Practicable, or judging how to weigh a risk against its benefits. This involves having to take a tricky decision in many situations

Risk index: A risk index is about assigning a score that will help determine the course of action when the risk index falls within categories

Residual risk: The level or extent of risk that remains after all the measures for risk control have been implemented.

There is more to medical device hazard analysis than these

The fact of having to take all these plus other factors into consideration for medical device hazard analysis makes it a challenging matter, because medical device hazard analysis should be done in such a manner that nothing is left to chance.

Want to understand the intricacies of medical device hazard analysis? Then, enroll for a highly relevant and absorbing session on medical device hazard analysis. This webinar is being organized by Compliance4All, a highly recognized provider of professional trainings for all the areas of regulatory compliance. Just log on to http://www.compliance4all.com/control/w_product/~product_id=501207?Wordpress-SEO to register.

Clearing the confusion about terms in medical device hazard analysis

At this session, Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker. He will throw light on all the confusing terms listed above. He will offer clarity on how to prepare a thorough medical device hazard analysis that will help those participating into this learning session.

Edwin will go step by step through a template for hazard analysis to help clear the confusion about the meaning of these terms and make the process clear. He will discuss examples of hazards and hazardous situations and explain how to deal with residual risk. He will walk participants step by step through a typical medical device hazard analysis.

Also explained in this session on medical device hazard analysis is the way of integrating Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

In the course of this lively discussion on medical device hazard analysis, Edwin will cover the following areas:

o  Explanation of Hazard Analysis terms

o  Hazard analysis process explanation using a template

o  Examples of terms will be given

o  Hazard analysis examples will be covered step by step.

http://blog.greenlight.guru/iso-14971-medical-device-risk-management

http://www.fda-consultant.com/risk1.pdf

http://nuhrise.org/wp-content/uploads/SOP-52-Adverse-event-reporting-for-medical-device-trials-SOP-NUH-sponsor-version-1.pdf

http://www.hse.gov.uk/risk/theory/alarpglance.htm

Taxable and nontaxable fringe benefits

The Internal Revenue Service (IRS) has guidelines and laws for the way fringe benefits have to be taxed. First, an introduction to fringe benefits: Anything that is in addition to a person’s regular salary may be termed a fringe benefit. It is usually linked to an employee’s performance. Some of the common types of fringe benefits include children’s education, vehicle for commuting to the workplace and back, health insurance, retirement benefits and many others.

The IRS taxes certain kinds of fringe benefits that come under designated categories, while some other kinds of fringe benefits are not taxed. Taxable and nontaxable fringe benefits are a major aspect of taxation laws in the US and have to be implemented in strict accordance with what is set out in the law. There is a long list of taxable and nontaxable fringe benefits.

A few examples of nontaxable fringe benefits

Stock options, employee discounts, savings that are made for retirement planning and other related benefits are part of nontaxable fringe benefits. Also, certain types of De Minimis benefits, depending on their value, need not be accounted for and filed under W-2.

A few examples of taxable fringe benefits

Other fringe benefits like accident benefit, vehicle that is provided from an employer and is for personal use, expenses incurred on vacation, and many other types of benefits are taxable and have to be accounted for and filed.

When declaring and filing these, the right method has to be followed. Filing for the said taxable and nontaxable fringe benefits has to be done under the appropriate head, following the right procedures. The right knowledge has to go into understanding what to consider as taxable fringe benefits and what to classify as nontaxable fringe benefits. Claiming the fair market value of taxable fringe benefits is of the essence in making the declaration of taxable and nontaxable fringe benefits.

Get to understand how to follow the right procedures for taxable and nontaxable fringe benefits

To gain a complete understanding of these aspects of the IRS, please enroll for a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This session will give a complete understanding of how to classify taxable and nontaxable fringe benefits.

At this important webinar, Greta Hicks, who is a former IRS Revenue Agent and Regional Training Coordinator, will be the speaker. She will take participants through all the important aspects of taxable and nontaxable fringe benefits that will help them understand how to get this right. To gain insights into how to get taxable and nontaxable fringe benefits right, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501196LIVE?Linkedin-SEO

Learn about the taxable and nontaxable fringe benefits to avoid penalties

This webinar is highly useful for those who have some confusion about taxable and nontaxable fringe benefits. Since there are many items that are classified under both taxable and nontaxable fringe benefits; clarity on each of these will go a long way in helping to understand the correct method of filing.

The learning from this webinar is important also because not only are the wrong expenses may disallowed by the IRS; filing under the wrong classification could result in penalties, too. Greta will offer complete clarity on benefits that can be hid in Sections 274, 162, 119, 132, 127, and 82. She will also give an understanding of numerous Announcements, Notices and Regulations, all of which have to be assiduously adhered to.

In addition, she discuss a few areas of taxable and nontaxable fringe benefits that offer scope for ambiguity, such as:

o  What are taxable and non-taxable as wages?

o  Are meal allowances nontaxable?

o  Are travel allowances nontaxable?

o  What other benefits are nontaxable wages?

o  What meals are 100% deductible and nontaxable to employees?

o  What meals are 80% deductible and nontaxable to employees?

o  What meals and entertainment are 50% deductible and nontaxable to employees?

At this session, Greta will cover the following areas:

o      Which benefits go on the w-2?

o      Do any benefits go on a 1099?

o      Fringe benefits you might be missing

o      Accountable employee reimbursement plan

o      What employee benefits are non-taxable to employees?

o      What/when expenditures are wages to employees?

Fringe Benefit Examples and How They Relate to W2 and 1099 preparation:

o      Accountable vs non-Accountable Expense Reimbursement Plans

o      Record keeping requirements of Sec. 274 & Accountable Plans

o      50%, 80%, and 100% Deductible Meals

o      De Minimis fringe benefits

o      No added cost benefits

o      Cash payments

o      Auto allowances

o      Company vehicles

o      Prizes, awards, gifts

https://www.hr360.com/Employee-Benefits/Fringe-Benefits/Introduction-to-Fringe-Benefits.aspx

https://www.paychex.com/articles/finance/taxable-vs-nontaxable-fringe-benefits

http://smallbusiness.chron.com/list-nontaxable-fringe-benefits-21172.html

http://www.moneycrashers.com/taxable-fringe-benefits-income/

https://justworks.com/blog/ins-outs-fringe-benefits-non-taxable

Risk of omission is a critical one in Quality

Omission is a very important, but often overlooked aspect of Quality. It is often not realized in most organizations that the risk not doing a thing right, or what may be termed risk of omission, usually outweighs and is far more dangerous than the risk of what they do wrong, or what is a result of poor quality. The best way to understand the importance of this paradigm is that poor quality generally comes out or makes itself known during inspections and tests, or when customers complain about it. These internal and external aspects are indicators of poor quality and show up, but the element of risk of omission does not have this option.

The silent killer

However, omission, on the other hand, is a silent killer, spotting which is extremely difficult. Who would have known, for instance, until Frank Gilbreth’s non-stooping scaffold demonstrated, that such a quotidian practice as bricklaying, which was being practiced by man for millennia, was being done in such a way that the normal practice was ending up wasting an amazing two thirds of the worker’s labor on non-value-adding motions?

It is when organizations equip themselves with the extra capability of spotting omissions like this that they stand out from the rest of the crowd and become world class performances. The ability to locate these otherwise invisible risks and opportunities is what distinguishes them from the rest.

Imbibe the skill for identifying the hidden

The ken for spotting this kind of small aspects should be cultivated into organizations. A hint of the ways of doing this will be the focus of a highly relevant and interesting webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. William Levinson, who is the principal of Levinson Productivity Systems, P.C., will be the speaker at this highly perceptive session. All that you need to do to enroll for this webinar is to visit http://www.compliance4all.com/control/w_product/~product_id=501033 to register.

Echoes in ISO

ISO 9001:2015 Clause 6.1 requires “actions to address risks and opportunities” with regard to the “context of the organization” and “needs and expectations of interested parties”. The standard also cites the SIPOC (Supplier, Input, Process, Output, and Customer) model, but the scope of this principle is not wide or deep enough to cover many existential risks and opportunities. The examples of Kodak, whose innovation outdated its own top selling product, and Toyota production system’s Seven Wastes show application of this ISO 9001 approach focuses only on one particular risk –the palpable one –while many more, far more potent ones could be lurking in the shadows, so to speak.

This leads to corrective and preventive action (CAPA) to remove the root causes of the problems in question. It is in dealing with the asymptomatic risks that organizations have to sharpen their nous. An organization that fails to do this loses opportunities to grow and be the leader.

Looking beyond the obvious

This webinar will offer some insights into the ways of doing this. The speaker will bring to bear his accumulated experience to narrate ways by which organizations need to look beyond the obvious in zeroing on the less conspicuous Quality issues.

He will dwell on the four key performance indicators, as developed originally by Henry Ford, which make it very difficult for asymptomatic wastes to hide under. These are cycle time, waste motion, waste of materials, and waste of energy. It is physically impossible for the last two wastes to hide from what chemical engineers call a material and energy balance, and its application supports ISO 14001 and ISO 50001. Enormous waste, along with risk of interruptions, can also hide in the supply chain. These aspects will be explained in detail.