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Top Articles - NFPA-70E Compliance Takes More Than A Label
Since the release of IEEE-1584 in September 2002 and NFPA-70E, 2004 Edition, I have talked with hundreds of facility engineers concerned about NFPA-70E arc flash hazard compliance. NFPA, the IEEE Safety Committee, and other groups have done a great job of spreading the word
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
regarding arc-flash hazards and the need to address this specific safety issue.
Unfortunately, most engineers I have spoken with are under the misconception that if they label equipment for arc-flash hazards, and enforce the use of personal protective equipment (PPE) per the
Unfortunately, most engineers I have spoken with are under the misconception that if they label equipment for arc-flash hazards, and enforce the use of personal protective equipment (PPE) per the
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
label, they are in compliance with 70E and OSHA requirements. Nothing could be further from the truth. Arc-flash hazard labeling and PPE compliance are only a small part of 70E compliance and even a smaller part of a properly defined safety program.
Very few facility enginee
Very few facility enginee
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s appear to understand the thought process behind 70E or the basis for the standard. If maintenance people are not informed why they must work within certain safety constraints, then the arc-flash label and PPE requirements become merely another task that can be sidestepped.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Safety as a principle
Gary McGuire, a safety manager for a large pulp and paper mill in the Northwest says, “Safety must be operated by principal, not practice.” He stresses the “why” of safety, not just the dos and don’ts of a task. This knowledge gives people confronted wi
Gary McGuire, a safety manager for a large pulp and paper mill in the Northwest says, “Safety must be operated by principal, not practice.” He stresses the “why” of safety, not just the dos and don’ts of a task. This knowledge gives people confronted wi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
h something out of the ordinary, the background to understand the potential dangers, enabling them to make safe choices. Safety is a culture that must be ingrained with principal. This culture starts from management and filters down to the worker where ultimate responsibility
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
rests.
The current arc-flash phenomenon appears to be operating on fear rather than principal. The fear is massive lawsuits and OSHA fines if an accident does occur rather than a sound reasoning as to why a safety culture makes good business sense in daily operations. While
The current arc-flash phenomenon appears to be operating on fear rather than principal. The fear is massive lawsuits and OSHA fines if an accident does occur rather than a sound reasoning as to why a safety culture makes good business sense in daily operations. While
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
it may have taken some fear in the initial movement to motivate companies toward implementing safety standards, if the safety aspect of arcflash is limited to labeling and PPE requirements, the inclination will soon wear off.
Labeling or stating PPE requirements will not pre
Labeling or stating PPE requirements will not pre
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ent accidents. Accidents are prevented and lives are saved through a foundation of safety.
NFPA-70E and the safety culture Several aspects of 70E in particular make good business sense and help promote a safety culture in
NFPA-70E and the safety culture Several aspects of 70E in particular make good business sense and help promote a safety culture in
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
your facility:
Article 205.2, 120.2(F)(1)(a) Updated and verified one-line diagram — An updated and accurate electrical one-line diagram is an essential ingredient for electrical safety. If workers do not have an accurate map of the system, they can be exposed to potential b
Article 205.2, 120.2(F)(1)(a) Updated and verified one-line diagram — An updated and accurate electrical one-line diagram is an essential ingredient for electrical safety. If workers do not have an accurate map of the system, they can be exposed to potential b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ck feeds from alternate sources, energized capacitors, undocumented switching conditions, and unknown voltages, in addition to the problem of not being able to accurately perform lock-out-tag-out procedures. This is one of the most neglected aspects of electrical safety in ou
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
industry. Very few of the facilities I have reviewed in the past 20 years maintain accurate electrical one-line diagrams. Accurate one-lines make good business sense because work will get done more quickly, efficiently, and safely.
Article 400.5, 400.6 Equipment duty verifi
Article 400.5, 400.6 Equipment duty verifi
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ation — Another important aspect is proper application and rating of equipment for the available short circuit duty. One facility I reviewed recently had underrated 13.8 kV breakers in an open switchyard. We informed them of the problem, but management did not take the warnin
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
seriously, since it had operated for twenty years without a problem. We were called in approximately a year later to inspect one unit that had exploded into hundreds of pieces of shrapnel-like metal!
Almost every facility has improperly applied equipment that will not withs
Almost every facility has improperly applied equipment that will not withs
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
tand the available fault current and potentially will not clear an arc-hazard. These types of accidents, while not common, are very dangerous. Properly rated and verified equipment makes good business sense. Unplanned outages and disaster recovery costs are expensive, and imp
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
operly rated and applied equipment can be considered negligence.
Article 110.7, and 130.1-3 Electrical Safety Program, Work Permits — In my opinion, this is the heart of 70E and worker safety. Without safety program principals, procedures, hazard/risk evaluation, work permit
Article 110.7, and 130.1-3 Electrical Safety Program, Work Permits — In my opinion, this is the heart of 70E and worker safety. Without safety program principals, procedures, hazard/risk evaluation, work permit
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
, and job briefing and planning, safety is relegated to a mere label with a PPE number. Workers are then left to fend for themselves “to get the job done” as many have done for years. When workers do not receive managerial support and are tasked with dangerous job functions,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
heir morale deteriorates and incidents increase. This seems to be an unrecognized cost in today’s business culture.
NFPA-70E is a comprehensive document that approaches safety from a system viewpoint, just as system engineers do when analyzing an electrical system. While I d
NFPA-70E is a comprehensive document that approaches safety from a system viewpoint, just as system engineers do when analyzing an electrical system. While I d
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
not agree with everything in 70E, I do believe the standard is well laid out and provides sufficient flexibility to allow tailoring a safety program to the individual facility. This is an important step in developing a “safety culture” for your facility.
As the word continu
As the word continu
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
s to spread regarding 70E, we hope more companies will begin to understand that labels and PPE do not fulfill the requirements for 70E compliance. Worker safety can only be implemented through principals and culture, which will in the long term pay benefits to the bottom line
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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