What is quality assurance?
Quality assurance is a critical component of a quality management system that's applied in a wide array of regulated industries, including life science.
The general definition offered in the US Code of Federal Regulations (23 CFR § 637.203) summarizes quality assurance as:
"...all those planned and systematic actions necessary to provide confidence that a product or service will satisfy given requirements for quality."
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Table of Contents
Quality assurance definition
How can the definition of quality assurance be understood in more detail?
In order for it to be effective, quality assurance means putting a formalized system in place by means of plans, policies and processes to assure that your products are manufactured accurately and in compliance with your relevant standards.
As a specific example, an FDA-regulated manufacturer’s quality management system (QMS) would be required to be in line with respective current good manufacturing practice (cGMP) requirements.
A quality assurance program would therefore be established to guarantee that outputted products align with those regulatory demands.
In addition to simply complying with their relevant regulations, as companies grow and evolve they may also impose tighter standards and quality objectives to improve customer satisfaction and overall product quality and safety.
Quality assurance could therefore be applied to ensure that internal quality benchmarks, such as a certain defect percentage or deviation rate, are hit and maintained.
FURTHER READING: The 5 objectives of quality assurance in the pharma industry
Quality assurance meaning
Quality assurance, or QA for short, means establishing a repeatable, measurable and proactive process into your manufacturing lifecycle that's aimed at preventing defects, errors and deviations from occurring, rather than just identifying and fixing them after they have already occurred.
The primary goal of quality assurance is to establish and maintain a particular level of quality throughout the entire lifecycle of your product and/or services. This involves defining your applicable quality standards, setting up processes and procedures to meet those standards, then monitoring and evaluating the results to ensure compliance.
Quality assurance typically means having several key activities in place, including:
Planning
Defining quality objectives, requirements, and standards for the project or process
Design and development
Ensuring that appropriate quality controls are implemented during the design and development phases to prevent issues and errors
Process implementation
Implementing processes, procedures, and guidelines to ensure consistent quality in the production or delivery of products or services
Inspection and testing
Conducting inspections, tests, and evaluations to verify that products or services meet the defined quality standards and requirements
Continuous improvement
Identifying areas for improvement based on feedback, data analysis and customer satisfaction metrics, then implementing corrective and preventive actions to enhance quality and prevent future issues
Documentation and reporting
Maintaining detailed records of quality-related activities, including test results, corrective actions and audit findings, then reporting them to relevant stakeholders for their input
We'll explore all these ingredients in more detail below.
MORE READING: How to achieve effective quality assurance
Quality assurance vs. quality control
A common misconception is that quality assurance and quality control are the same thing, and while they might be under the same umbrella, they are operationally different.
So how does quality assurance differ from quality control?
Quality control is the set of steps put into place to check the compliance and accuracy of a product (or service) after it is produced.
One way to understand the contrast is to think of quality assurance as a 'proactive' or 'preventative' process, with quality control as the 'reactive' process put in place for reviewing and checking products after they are manufactured to ensure no defects or faults have emerged.
So for quality assurance: think processes put in place to assure quality before the fact.
For quality control: think 'inspection' steps after the fact, to check and 'control' the product and resolve any issues before it reaches the customer.
Both are important for ensuring the end quality of your product and service, but come into play at two different points in the manufacturing process.
And in the totality of your quality management system, quality control is often considered a subset of your overarching quality assurance measures.
Source: ASQ
FURTHER READING:
What is quality assurance vs. quality control? 5 key differences
Best practices for quality assurance
Like any quality management discipline, quality assurance requires careful application of measurable best practice.
QA is impossible without measurability - you need to be able to chart your organizational progress towards a particular set of quality benchmarks in order to know whether your initiative is working.
With that in mind, it's useful to have a handful of key metrics in place.
Quality assurance metrics
Clause 9 of Annex SL, the high-level structure governing all modern ISO standards, lays out 'performance evaluation' as a cornerstone of your quality assurance activities.
A set of 'North Star' metrics should be in place.
Consider things like:
Give yourself a clear mechanism for continuously measuring and reviewing your key quality assurance metrics, and use them as the guiding light of your QA program.
Benefits of quality assurance
Because quality assurance plays such a crucial role in ensuring that your products, services and processes meet established standards and fulfil customer needs, it unlocks some powerful knock-on benefits for your business when it's done right:
Customer satisfaction
By ensuring quality throughout the entire development or production process, robust QA slices the risk of defects, errors and other factors which might cause customer dissatisfaction
- Cost savings
Quality assurance helps you to proactively pinpoint and resolve issues early in your processes, preventing them from escalating and becoming more expensive to fix later.
The need for rework and repairs, and to address customer complaints, is sliced, unlocking significant cost savings.
The '1-10-100' rule holds that $1 spent in defect prevention (quality assurance) is equal to $10 spent in product appraisal (quality control) and $100 spent on fixing product failures.Increased productivity and efficiency
QA processes often involve streamlining workflows, standardizing procedures, and implementing best practices. By doing so, QA helps reduce waste, optimize resources and eliminating redundant steps and activities.
Risk mitigation
QA helps to identify and mitigate risks associated with product or service failures, non-compliance and customer churn. Failures, recalls and reputational damage are all much less likely with a robust assurance program running.
Improved decision-making
Done properly, quality assurance provides valuable data and insights about the performance, reliability and quality of your products, services and processes. With the right tools, your organizations can identify trends, patterns and areas for optimization.
Quality assurance program
There are numerous quality assurance techniques, philosophies and methodologies which might be mandated by a regulator or demanding customer.
For FDA quality assurance, your quality management system should encompass the entirety of the policies, objectives, procedures, work instructions and so on that put in place to meet your customer and regulatory requirements, and assure that cGMP is in place.
Another well-known quality assurance framework is derived from ISO.
ISO 9001:2015 is the most widely recognized international standard used for quality assurance. Other industry-specific standards, like ISO 13485 for medical devices, all derive from the general ISO 9001 quality assurance roadmap.
Total Quality Management (TQM) is another method, whereby your entire company is trained and involved in improving processes, products, services and the culture in which they work. TQM is customer-focused, and all employees are empowered to make continual improvement in the system for the betterment of the customer.
There are many more. These are just the most well-known, however they all have an end goal of quality assurance to improve customer satisfaction by ensuring the requirements within align to develop and manufacture products that meet required standards.
Quality assurance plan
This is another common question among quality professionals. What is a quality plan, and is it required for quality assurance?
It's not always cut-and-dry, but as an example, the FDA does mandate a quality plan in addition to the medical device GMP procedures and instructions in 21 CFR 820.
The FDA stipulates that a device manufacturer:
"...must have a written quality plan that defines the relevant design and manufacturing quality practices, resources and activities and how they intend to meet their quality requirements."
One might liken the quality plan required by FDA cGMP to the quality manual required by certain ISO standards.
A quality plan should map out in high level, executive summary format what is required for your company to be successful in embedding quality assurance for the manufacturing of your products.
A quality plan may look different depending on your specific requirements, but they should define the major elements required to meet your company’s quality objectives and how they interrelate and interact.
Quality assurance tools
The ingredients and tools which feed into your quality assurance activity include:
- Quality policy with specified quality objectives (and how you'll measure them!)
- Appointment of quality management representative with authority to make necessary changes that ensure the QMS is effectively established and maintained
- Frequent, documented reviews of the quality system against your quality requirements and your defined quality objectives, with reports to senior management
- Organizational structure and resources adequate to ensure your products are designed and manufactured in accordance with your quality benchmarks, whether that's cGMP, ISO compliance, or something else
- Citing of the specific standards, procedures and instructions to be applied to meet your quality assurance objectives
There is no set quality plan format.
They may include different types of documents and visual aids to best represent your assurance plan for high-level review.
As long as it covers all parts of your quality system and includes the resources required to meet your desired quality outcomes, you should have the clear framework in place that you need to execute your quality assurance plan.
Quality assurance jobs
As a regulated company begins to grow and search for customers and funding, it's crucial that quality measures are put in place to streamline processes and ensure you're delivering quality products to your customers.
Astute business owners and CEOs have come to learn that quality and overall reputation affects the bottom line, so it's in their best interest to put the necessary QA staff in place.
The larger the company, the larger the quality assurance team they need to fulfil their desired outcomes.
Quality assurance jobs description
To help understand the role of quality assurance, it helps to explore a few of the typical roles connected to the quality assurance profession.
These are just a few examples of quality career positions and their basic functions and objectives.
Document control specialist
One of the entry level positions for a quality assurance professional might be a document control specialist or a quality associate.
They are in charge of managing a company’s forms, records and procedures in accordance with company and regulatory standards.
They may be asked to scan and retrieve records upon the request of superiors for customers (RFIs) and/or during audits to ensure they are disseminated in accordance with company and regulatory standards.
They may assist with other duties within the quality assurance unit as needed.
Quality assurance engineer
A quality assurance engineer is responsible for ensuring the overall quality of manufactured products, which can be in a variety of regulated settings.
Duties generally include creating the company’s quality standards and testing processes to ensure efficiency and reliability to drive increased product output.
They continually monitor and report issues and errors found, with an eye toward solutions. Education required is usually a 4-year bachelor’s degree in engineering or related field, with preference of master’s degree. Career advancement leans towards a managerial or executive level position.
Quality assurance manager
A quality assurance manager will help companies establish quality management systems (processes, instructions and quality standards) that fall in line with their respective regulations.
They are in charge of designing, implementing and continuously improving their company’s quality standards. They review, audit and assess to ensure their company is compliant.
Based on their findings, they must have autonomy to make changes in the system where merited, for the company to be successful in their desired outcomes of product quality.
As this is usually a daunting task, they assist in recruiting, hiring and training detail-oriented subordinates to help them meet company and industry standards.
The quality assurance manager (unless there is a higher top-level quality professional) is usually designated as the management representative (as described above).
As management representative, they will be the company liaison during audits and meetings with FDA, EMA, MHRA, TGA or ISO auditors, and so on.
They are responsible for training and motivating all members of the company in quality related objectives, as well as providing feedback to upper management of quality findings and recommendations for corrective actions.
RELATED READING:
How a QA director freed up a week every month for continuous improvement
Quality assurance specialist/quality assurance analyst
Quality assurance specialist positions are in line with quality assurance management duties, however they are usually closer to the bench.
And in some instances they may have recently worked on the quality control side and have hands on experience of issues found and the bench knowledge to correct them.
QA specialists can work in a wide array of industries from life science and aerospace engineering to software development. They work to implement testing plans and procedures for products to ensure they meet company, industry and customer standards.
They also work to improve product and process efficiencies based on continual monitoring and analyses.
Continuous improvement manager
Continuous improvement managers work in a variety of settings, not just regulated industries, although they are inherently beneficial within production and manufacturing companies.
They work with multiple departments with an eye towards business efficiencies, creating change improvements where necessary to streamline processes and/or help the bottom line. They find solutions by forecasting the benefits of change by assembling and analyzing data using flow charts, spreadsheets and other documentation.
CIMs are usually not a mandated position like a quality management representative is in FDA-regulated industries, so they're usually found in larger companies seeing the big-picture benefits of quality assurance without the mandate.
Since they work in various industries and across many departments, they need a bachelor’s degree in relevant fields of business management, finance or accounting.
Experience with enterprise project management tools and Six Sigma is usually a must and will help you move up the salary rungs.
Quality assurance auditor
Quality assurance auditors can be found in a variety of settings, but are usually found in regulated manufacturing industries.
They inspect products and the flow of processes to ensure they align with written procedures and compliant to their respective industry standards.
They interview employees to ensure all levels are on board and aligned with quality assurance implements.
A quality auditor can be internal (reviewing their own company’s processes for compliance) or external (reviewing your company’s suppliers for compliance or as a government or certified quality auditor).
Auditors spend a majority of their time reading and keeping abreast of industry standards, as well as planning, conducting and writing up audit assessments. After audits are completed, they manage post-audit activities following up on any necessary corrective actions that may have been found during audits to officially close them out. Auditors must be detail oriented and very good at communication, verbal and written.
Quality assurance consultants
Quality assurance consultants are well seasoned in their field of study and may come from various backgrounds of expertise, usually garnered in the corporate world.
They may specialize in pharmaceuticals, medical devices, ISO compliance, international standards, and so on.
Small companies may hire them to conduct all of their quality needs, whereas a medium or larger size company may hire them to round out their quality unit where it is lacking, or for specific projects where quality professionals are merited.
There are a variety of reasons for hiring an outside QA consultant; your regular employees may be tied up on day-to-day needs, or may not have the specific expertise for a necessary project. A pair of dedicated QA hands could complete and/or train your quality team on the task.
A quality assurance consultant must be well versed at verbal and written communication, as they will most certainly be asked to advise companies on their procedures compared to mandatory regulations.
Quality assurance certification
Nothing beats hands-on experience, but if you're looking for upward mobility in your quality assurance career, a higher education or specialty certification could be the key that unlocks metaphorical doors.
Quality certifications can be a powerful way to show employers you are invested in your career, and some employers may pay for you to obtain them.
QA certifications don't usually take long to obtain, but they often come with expirations and usually require you to either retake the tests in future, or to show proof of continued training to keep your certification valid.
Bodies like the American Society for Quality (ASQ) offer a variety of quality certifications that can be obtained with some real-world knowledge (most require years in the field first) and some focused study.
Once obtained, you have to renew every few years by showing you are continuing to work and train in the field. You can use the letters of the obtained cert after your name to show others at a glance you are in the know in your specific field.
Here are a few common quality certifications that should increase your overall value and may be a stepping stone to your desired quality assurance position:
CQAP - Certified Quality Assurance Professional
You will receive a diploma showing you're certified in the field of quality assurance from PIQC. It's a 4-month online course, where participants work on real life projects preferably from the organizations they already work in to show understanding of the concepts.
CQA - Certified Quality Auditor
CQA certification ensures you understand the standards and principles of auditing and auditing techniques to include examining, questioning, evaluating and reporting to determine a quality system’s adequacy to relevant standards and QA benchmarks.
CQE - Certified Quality Engineer
CQE certification proves you understand the principles of product and service quality evaluation and control. CQEs can use statistical methods to diagnose and correct quality control processes, all the while understanding human factors.
Six Sigma is a process to optimize outputs of production for efficiency (which can also incorporate lean manufacturing where you are focused on removing non-value added steps).
Six Sigma and lean manufacturing alike has been adopted by companies all over the world to remove the cause of defects and conversely increase profits. The main steps in Six Sigma are known as DMAIC (Define, Measure, Analyze, Improve and Control). There are numerous providers for Six Sigma certification, and many different levels, so you would have to find one that is best for your needs. As some of the others above, ASQ does offer certification in black, green and yellow belt certification, some with lean principles integrated.
RELATED READING:
What are the best pharmaceutical quality assurance courses online?
Quality assurance training
Degrees in quality are becoming a more popular way to get deeper QA training, but they are still few and far between, so it may be better and easier for you to further your education in your desired industry of life science, engineering, and so on.
With a quick search you can find a few higher education degrees in quality across the United States, but you are more likely to find courses or training webinars.
You can expect a quality degree or quality courses to teach you the basics in quality management systems, quality auditing, statistical tools and quality concepts to prepare you for real-world implementation.
|
School |
Program |
|
Cambridge College Global |
Bachelor of Science in Quality Systems and Improvement Management (online) |
|
Hempster Shire University |
Bachelor’s Degree in Quality Management (online) via School of Business and Management |
|
University of Minnesota Crookston |
Bachelor of Manufacturing in Quality Management (online) via Business Department |
|
California State University |
|
|
University of Central Florida |
Quality Assurance Certificate (online) via Computer Engineering College |
And of course, if you're just looking to brush up on your skills or round out your knowledge, you can always look for webinars that match your budget and needs.
With a quick Internet search you can find quality assurance courses on statistical tools, ISO requirements, lean and Six Sigma principles, total quality management, and so on.
Make quality assurance natural and automatic in your business
Quality assurance unlocks powerful benefits for your organization, if it's done right.
Good QA demands careful coordination of documentation, employee training, process management, product risks, and even your supply chain.
As we've seen, quality assurance is all about adding value to your business by proactively spotting and fixing anything that threatens or undermines your product and service quality.
Unfortunately, modern quality professionals in regulated industries like life science are struggling to dedicate suitable amounts of time to quality assurance activity.
A 2023 life science quality trends report found that over three-quarters of respondents could allocate no more than 25% of their working time to QA tasks. 10% had no time at all for quality assurance.
Admin and after-the-fact quality control work continues to take up inordinate amounts of time in organizations reliant on legacy quality management tools like paper and spreadsheets.
In turn, QA and continuous improvement initiatives suffer, holding companies back from their full potential.
Electronic quality management systems like Qualio digitize and automate your quality system, slicing non-value-add and admin time from your working week and giving you the headspace to focus on quality assurance and the operational benefits that come with it.
Here's the real story of a QA manager whose life got '100% better' with a digital approach to quality.
Book a demo with Qualio to see how it works!
