The role of a Quality Engineer can vary greatly between companies.
In larger manufacturing operations, quality engineers can have a specific focus or area of expertise such as Quality Assurance, Quality Control, Six Sigma, Quality By Design, The Taguchi Method, Quality Risk Management or even Reliability Engineering.
– is process-oriented and focuses on eliminating process variation by creating, revising and strictly implementing a set of tightly and precisely defined process/procedures/quality standards that when exactly followed, ensure the final quality of the product. Quality Assurance is preventative by nature.
Quality Assurance is typically reflected on the factory floor through the use of a Quality Management System (QMS). A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization’s activities to meet customer and regulatory requirements.
ISO 9001:2015 is the most recognised and widely implemented quality management system. Other techniques and methodologies used in Quality Assurance are Deming’s 14 Points, Total Quality Control, and Total Quality Management.
– is product-oriented and focuses on testing a sample of a manufacturing process to make sure that it meets the required design specifications or quality standards. In pharmaceutical manufacturing, the sample testing is done in a laboratory so people who work in QC usually generally (but not always) have a science/laboratory background.
100% sampling or Statistical Process Control (SPC) are some of the more widely used techniques in quality control.
– is a set of techniques and tools for process improvement developed by Motorola and gained industry-wide acceptance after it was championed by Jack Welch at General Electric. It aims to improve the output quality of a process by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. More recently, Six Sigma has been combined with Lean Manufacturing to form Lean/Six Sigma to eliminate waste and provide a framework for organisational and cultural change.
Quality by Design (QbD)
– quality by design is a concept first developed by the quality pioneer Dr. Joseph Juran. Dr. Juran believed that:
- quality should be designed and built into a product
- more testing doesn’t necessarily increase the quality of the product. It can often have the opposite effect
- most quality crises and problems relate to the way in which a product was designed in the first place
More recently, the Food and Drug Administration (FDA) in the US has started to encourage risk-based approaches and the adoption of quality by design principles in drug product development, manufacturing, and regulation due to the realisation that increased testing may not always improve product quality. Quality must be built into the product.
Taguchi Method of Quality Control
– developed by Dr. Genichi Taguchi of Japan, this method has at its basis, value for the customer where quality is defined as “the loss imparted to society from the time a product is shipped”. The loss is defined mathematically by what he calls the loss function. Taguchi prescribes the use of low-cost off-the-shelf proven parts, materials that work over a wide range of conditions, and statistical experimentation.
Quality Risk Management (QRM)
– makes extensive use of worst-case scenario planning to figure out what could go wrong and come up with steps to mitigate those risks. Think of it as a way of visualizing catastrophe before it happens and coming up with preventive steps either by designing out the problem (preferred) or procedurilize-out the problem (last resort). This methodology is used extensively in manufacturing, testing and distributing pharmaceutical or medical device products.
– uses engineering techniques and statistical analysis to improve the dependability or reliability of a product or process that’s subject to vibration, shock loading, voltage, radiation, extreme temperatures, fatigue or other environmental factors for a required time duration in a specified environment in order to:
- Prevent or reduce the likelihood or frequency of failures
- Identify and correct the causes of failures that do occur despite the efforts to prevent them
- Determine ways of coping with failures that do occur, if their causes have not been corrected
- Apply methods for estimating the reliability of new designs
Reliability engineering is used extensively in aviation, aerospace, automobile manufacturing, steam turbine design and nuclear power generation.
In smaller operations, Quality Engineers can be tasked with a much wider remit of responsibilities, providing quality engineering support to the whole system.
Based within the manufacturing facility, Quality Engineers can work on the manufacturing floor, in an office, or in a lab – depending on the specific tasks they are carrying out at the time.
As previously mentioned, the specific duties of a Quality Engineer will vary from company to company. But as examples, they can include:
- Creation of quality documentation and development of SOPs for their facility and products in line with industry standards
- Proactive review and improvement of systems and processes to ensure the maintenance of standards
- Maintaining accurate quality documentation
- Working closely with manufacturing staff to ensure quality protocols are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review
- Inspection and testing of various parts of manufacturing including products, components, processes, and comparing against predefined standards
- Ensuring safety requirements are met at every point in the manufacturing facility
- Analysing problems reported and developing improvements to overcome them
- Oversight of junior quality team members
- Statistical analysis of manufacturing data and creation of reports for senior staff members based on quality documentation
- Working closely with external partners e.g. suppliers, customers, etc
- Continuous improvement in the manufacturing process