The manufacturing process is designed to quickly mass-produce exact replicas of a product. Each unit must meet clearly defined quality standards, meaning it should match the prescribed aesthetics and function properly for its intended use. Additionally, each unit must meet specified safety standards, which include being able to withstand a reasonable level of misuse. The manufacturer must achieve these goals at a reasonable price point for the client company. Unfortunately, not every facility can meet these expectations. Sometimes, due to inconsistencies in processes and materials, manufacturing defects creep into a batch of products. That creates all kinds of problems, as you try to salvage what is usable and separate defective products that could potentially harm consumers and ruin your brand’s reputation. In many cases, the whole order must be scrapped. Delays, losses, and potential liability are problems you don’t need, especially when you’ve put in so much work and you’re so close to launching your new product. So, how do you protect your company from potentially ruinous results? By partnering with a manufacturer that emphasizes quality at every stage of the manufacturing process.
Designing Quality into the Manufacturing Process
In a previous blog, we discussed the importance of Design for Manufacture, an essential step in the product development process that prepares your design for mass production. But even the best DFM work is useless if the manufacturing processes aren’t also designed to produce a quality product. This is where Quality Management comes in. This is a two-pronged approach that includes:
- Quality assurance — The preparatory and preventative aspect of quality manufacturing ensures that a supplier can meet the client’s goals for the product’s aesthetics, function, use, and lifespan, as well as safety requirements outlined in the common law and regulatory guidelines for specific markets.
- Quality control — The “inspect and detect” aspect of the process oversees each phase of manufacturing to spot potential problems immediately remedy the issue and improve the process for future production.
When managing quality, a supplier can never be complacent. Rather, everyone involved must be actively engaged, looking for opportunities for process improvements that can deliver value for the client.
The Role of Quality Assurance in Contract Manufacturing
To achieve optimal results, QA should start even before DFM and continue throughout that process. The earlier QA begins, the greater its impact. This early start allows for ongoing articulation and collaboration between QA and DFM, leading to superior decisions on matters such as design elements and materials. Since there is no way to separate product from process, we cannot perfect one independently of the other. Thus, a synergistic approach between QA and DFM elevates quality, enhances efficiency, and reduces cost. At Genimex, we believe our integration of QA into our product development process is one of the key ways we add value for our clients.
So, ultimately what is Quality Assurance? QA consists of all preparatory steps that ensure the facilities and processes are ready/able to mass produce the product according to specifications meeting the standards of the client, the market, and all pertinent regulators. Quality assurance involves:
- Designing and implementing processes with a holistic approach that considers market factors, regulatory requirements, experiences of similar products, cost constraints, manufacturability, and real-world use by actual consumers.
- Strong communication that elicits pertinent information from a wide range of stakeholders, including the client, suppliers, manufacturing partners, marketing professionals, and consumers.
- Verification and improvements through multiple rounds of testing for prototypes, first article parts, pre-production, and production.
There’s an adage that says, “Amateurs practice until they get it right; professionals practice until they can’t get it wrong.” QA is the stage of comprehensive, even exhaustive, preparation that seeks to eliminate any chance of a mistake making its way into the process.
How Qualification Planning Supports Quality Assurance
Qualification is the process by which a supplier proves they have appropriate equipment, sufficiently skilled laborers, and other assets needed to meet or exceed the project’s specified requirements. You want to do business with suppliers who take pride in the products they produce and go the extra mile to ensure your satisfaction and repeat business. Genimex has spent decades vetting suppliers who are conscientious and reliable, and we have built a reliable network. We have also developed a sophisticated factory audit to aid in the selection of the best facility for each client’s needs.
Importantly, we have onsite quality assurance personnel performing numerous duties that are critical for successful QA:
- Genimex dedicates professional QA engineers to each project. Our QA personnel collect CTQ (Critical to Quality) and CTC (Critical to Client) data points during the project development phase and use these to design processes to meet quality requirements.
- QA engineers identify the legal and compliance requirements of regional markets and list them in our Validation and Verification Test Plan (V&V Test Plan). Only after the product passes every test item in the plan do we approve it for Pre-Production and Mass Production.
- QA drafts the quality inspection standards used to qualify finished products for shipment.
Comprehensive planning is the key to creating processes that can achieve the client’s goals and placing those processes in the capable hands of proven suppliers.
Key Advantages of Onsite Quality Control for Outsourced Manufacturing
Having an outstanding plan is essential, but ultimate success also relies on the implementation of that plan. This is the job of Quality Control, the process of inspecting results at every key point in the process to ascertain whether the processes are working as designed and to make any necessary adjustments. Thus, QC relies on two basic principles:
- Frequent inspections of performance — Frequent, random inspections are an important safeguard. With onsite personnel, there is greater flexibility to arrange During Production Inspection (DPI), and Final Random Inspection (FRI), to ensure units are made per quality standards. Genimex can perform inspections at every key point of the process.
- Continual improvement through quality engineering as required — When a defect appears, its cause must be determined and the flaw in the process must be remedied. The Genimex quality control staff includes experienced quality engineers who can diagnose a process issue and offer a solution that improves the process and keeps production on track.
Genimex delivers on the promise of Quality Control because we have built a highly efficient team of dedicated professionals. Our Quality Control team consists of more than 25 professional staff, including a Quality Director and a team of quality engineers. So, instead of relying on a disinterested third party to safeguard your production processes, you have a loyal and motivated agent, who is determined to deliver a product that they and you can be proud of. Adhering to a strict, preplanned inspection schedule, our team can detect problems early and quickly engineer solutions, adjusting the process for improved performance.
Genimex is with your product every step of the way.
The Genimex QA/QC team is looped in from the beginning of a project to ensure that appropriate quality standards are understood, implemented, and achieved. Genimex’s experience over the last 50 years enables us to manage quality for various product types, materials, and conditions to meet the quality standards we expect and you demand. We have earned a reputation for consistent success in meeting or exceeding quality standards, so our clients can be as confident as if they were at the actual worksite, even while they’re half a world away.
