Three Industries With High Quality Assurance Standards
Hello friends, I hope you all are doing great. In today's tutorial, we are going to discuss Three Industries With High Quality Assurance Standards. If someone asked you to bet $1 million on which industries had the highest quality assurance standards, the smart money would bet on the industries that are most heavily-regulated.
How do you know if an industry is heavily-regulated? See if there’s a government bureau named after that industry. Another good indication is if lives and public health hinge on the industry doing its job correctly.
Or, just work in a heavily-regulated industry. You won’t be able to walk from point A to point B without quality assurance implications. Successful enterprises in heavily-regulated industries approach “quality standards” in three tiers:
- Quality Assurance (QA): The high-level proof submitted to the public, and—more importantly—regulators that your products are of sufficient quality.
- Quality Management System (QMS): A series of processes that delivers quality assurance by implementing quality control.
- Quality Control (QC): The “boots-on-the-ground” act of rooting out and eliminating problems that might hinder quality production.
Most heavily-regulated industries have established, often international quality assurance standards to meet, as well as time-tested quality management systems to implement quality control. Here are three industries with high quality assurance standards.
Pharmaceutical Industry
The pharmaceutical industry is heavily-regulated for good reason. Governments have a public trust to make sure products they consume are safe and do what they are supposed to do. A faulty drug formulation could hurt or kill consumers or contribute to a public health crisis rather than alleviate it, with
lawsuits following close behind.
The key regulatory agency for pharmaceuticals in the US is the FDA (Food and Drug Administration). Pharma companies typically must comply with multiple sections of FDA 21 CFR (Title 21 of the Code of Federal Regulations).
Pharmaceutical quality assurance focuses on:
- Public Safety: Medications can change someone’s life for the better or cause serious harm. Quality controls to protect public safety include strict attention to document control, employee training, laboratory OOS, corrective and preventive action (CAPA), internal audits, and managerial review.
- Professional and Consumer Confidence: Edelman’s 2019 Trust Barometer rated the public trust in the pharma industry at 57%, worse than any other healthcare vertical. Robust attention to quality assurance is necessary now more than ever to regain consumer and professional confidence.
- Production Efficiency: Production efficiency allows safe products to be produced at a lower cost, increasing profits and fostering affordability severely lacking in the industry. Companies can improve production efficiency through automated data collection and holistic data integration.
Medical Devices Industry
The FDA and its international counterparts also keep the medical device industry on
a short leash, as much if not more so than the pharma industry. “Medical devices” is actually a fairly broad category of healthcare-related devices, covering such categories as:
- Physical Devices: Medical devices that live at or come from a hospital, like MRI machines, pacemakers, and defibrillators.
- IoT Devices: Short for “internet of things,” IoTs are a class of physical device that perform functions via the internet. Examples include blood glucose monitors and dissolving EEG monitors that transmit data by wireless signal or into the cloud.
- SaMD: SaMD--“Software as a Medical Device”--refers to software that performs the function of a medical device, regardless of the device it is in (i.e. smartphones, smart watches, tablets, etc.) Examples include software that uses the microphone or accelerometer in a smartphone to record breathing data or tremors.
While not always “consumable” in the way medications can be, medical devices have risks of their own, like radiation from an X-ray machine. Some hospitals even use sophisticated robots to perform heart surgery. Quality assurance is obviously paramount for a device like this. Other medical devices, like pacemakers and blood glucose monitors, are implanted in the body, where they could do significant harm if not manufactured to exacting quality standards.
Key quality assurance guideposts to keep in mind include:
- Corrective and Preventative Actions (CAPA): Procedures to correct quality management failures.
- Complaint Procedures: How to receive, document, and respond to customer complaints, including tracking and close-out procedures.
- Reporting Procedures: Including written procedures for reporting data and key descriptions in compliant form.
- Nonconforming Product Procedures: Nonconforming products and materials are commonplace and acceptable if appropriate controls are applied.
Aerospace Industry
The aerospace industry sits at the intersection of
multiple regulatory purviews, resulting in one of the heaviest compliance burdens of any industry. Millions of consumers who depend on commercial aviation and medivac helicopters are counting on the industry’s compliance and safety.
Regulatory agencies with oversight over the aerospace industry include the Federal Aviation Authority (FAA), the Department of Defence (DOD), the National Aeronautics and Space Administration (NASA), and the Environmental Protection Agency (EPA)--and that’s just in the US.
The key quality assurance control that applies to aerospace manufacturing is AS9100, also known as AS9100D due to Amendment D. This standard was created by the International Organization for Standardization to adapt quality assurance control standard ISO 9001 to the specific needs of the aerospace industry.
Dickson states that the standard is quite comprehensive, noting that it covers company policies, procedures, and documentation.
Not only do aerospace manufacturers have to comply with AS9100D, but so too do their suppliers and subcontractors. International agencies, like the EU, often adopt versions of the standard that are basically identical.
AS9100 is also divided into three standards:
- AS9100: Aerospace design, development, and manufacture.
- AS9110: Aircraft maintenance organizations.
- AS9120: Distributors of hardware, electronics, and other materials.
Aspects of AS9100 to be aware of include:
- Development and Design: Standards for new products.
- Purchasing: Selection of vendors, purchasing procedures, validation and verification.
- Traceability: Being able to trace processes to the accountable party.
- Risk Management: Reducing QC risks where possible, accepting and managing risks where not.
At the end of the day, burdensome as quality assurance may be, the industries that require extensive QA typically do so from a position of public trust. QA failures are often high-profile and disastrous in this industry, undermining their credibility at times when they need it the most to keep innovating and improving the landscape of human experience.
Understanding quality assurance standards for heavily-regulated industries serves as an excellent guide even for industries that don’t depend on them. The compliance burden may be less weighty, but public trust and a reputation for quality never hurt
any business in
any industry.
5 Engineering Career Paths Worth Considering
Hello friends, I hope you all are doing great. In today's tutorial, we will have a look at 5 Engineering Career Paths worth considering. If you’re an
engineering student or graduate and you later realize that this field isn’t what you had expected it to be, then all is not lost. As a matter of fact, there are a number of
career paths available for engineering students and graduates from around the world.
First and foremost, being an engineer isn’t just about doing one job. Truth be told, engineering focuses on a wide range of careers. Even though every engineering career shares a set of crucial general skills, they eventually branch out into several other types of fields that require very unique and varying skill sets.
Put simply, the skills that you learn as an engineer will be valuable in various other fields. You can either go to different specializations of engineering or even look for a similar job at a different company if the current place you’re working in is not up to your liking.
Fortunately, engineering also involves problem-solving skills, training, and analytical prowess which you can apply somewhere else without having to take an extra course from a college or vocational school.
But before we show you some of the most prominent engineering career paths there are a certain number of prerequisites that you need to keep in mind.
1. Start from The Bottom
No matter what discipline you are in, you’re always going to start from the ground up, which is as a junior level engineer. This is an entry-level spot where you learn the ups and downs of the engineering industry from your senior engineer.
A junior engineer’s responsibilities will depend on a certain branch of engineering, but it usually focuses a lot on gathering and deciphering data, engaging in fieldwork, testing products, and helping out in documentation and reports.
2. Get Your Professional Engineer License
The next thing for you to do is to acquire a professional engineer license. With it, a vast sea of opportunities can open up for you. It’s also something that you can look towards when giving your career an early start.
As a licensed professional engineer, you will legitimately be allowed to practice engineering in your territory or province, as well as take legal responsibility for your job. The credibility that you get with having a license will offer you astounding benefits if you wish to start your own business or even start work in consulting later on.
Now let’s look at several career paths for engineering that you can opt for:
Best Engineering Career Paths
Let's now have a look at few Best Engineering Career Paths:
1. Fashion Engineer
Yes, believe it or not, becoming a fashion engineer is indeed an engineering career path. There are quite a handful of engineers who are interested in the fashion industry. This field of engineering, especially that of the ever-growing modern fashion landscape, values those who possess skills in science and math.
In fact, several renowned fashion brands like Louis Vuitton and Nike are trying to figure out how to implement technology into their clothing line up, echoing in a new era of smart wear. Think about how cool it would be to be part of a group that builds plausible 3D printed clothing solutions.
Besides that, you might also be able to lend a hand in developing machines that can make clothing as well. So, if you’re someone who is into fashion, and also loves engineering, then this is the right career for you.
2. Civil Engineering
Civil engineering involves planning, designing, constructing, and maintaining infrastructures of various shapes and sizes. Apart from covering a wide set of structural and civil engineering disciplines, civil engineering can act as its own career path and discipline.
This field involves being able to plan, design, and maintain structures both on a small and large scale. Civil engineers can design an entire building or else be involved in developing a whole transport system
A civil engineer should also be mindful of real-life considerations or concerns. What this means is that civil engineering can be intertwined with financial, environmental, ethical, and legal issues. It’s the kind of engineering where one will always be involving theoretical problem solving with a real-world, practical application, that is inspired by the needs of the entire community.
If you’re interested in construction management, which is a key component of civil engineering (many engineers do both over their careers), then you can
learn more about it here.
3. Mechanical Engineering
Mechanical engineering is the study of energy, force, and motion. Mechanical engineers sought to control these elements by using a mix of human and economic resources, and material to develop mechanical solutions that satisfy the wants and needs of society. Mechanical engineers have the following common responsibilities:
- Product design
- Manufacturing
- Research and development
- Energy
- Systems management
In many of these areas, mechanical engineers seek to create or harness energy in machines like air conditioners, refrigeration equipment, and boilers. Product design involves designing as well as manufacturing physical products like personal computers, dishwashers, and engines.
4. Electric and Electronic Engineering
Another interesting engineer career path is electronic or electrical engineering. Both of these are focused on applying electrical power. Electrical engineering is more about the production and supply of electrical power, whereas electronic engineering focuses more on smaller electronic components like the ones used within computers.
To understand how much electrical and electronic engineering has impacted the world, you should know that it has led to the creation of radio, universal electrical power, medical imaging, or television technology.
5. Environmental Engineer
Environmental engineers specialize in chemistry and biology to understand and develop solutions for environmental issues. This is especially essential considering the world is constantly plagued by climate change. Environmental engineer services are of great importance in areas of recycling, reduction of water and air pollution, as well as waste management.
And thanks to governments and companies coming up with the latest and innovative green initiatives, there is an exceedingly high demand for environmental engineers. What’s more, is that there’s usually plenty of traveling involved for environmental engineers who can go anywhere around the world and visit exotic locations.
