In this episode, we speak with Mary Sennett, Tapecon’s Quality and Compliance Manager. Mary has 25 years of experience in the manufacturing industry. Mary discussed Tapecon’s compliance system, including documentation, inspections, and quality testing, and how we fulfill requirements for different industries. Mary also explained why a thorough understanding of process validation is valuable to brand owners.
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Mary Sennett, Tapecon’s Quality and Compliance Manager, has been with the company for nine years.
Tapecon’s customers depend on us to understand their market and its requirements, both in terms of expectations for their customers and regulations that govern their industry.
Tapecon uses a similar “best practices” validation process across all industries, although some steps vary due to a product’s intended use.
We always use specific, appropriate steps for every product or component.
Documenting and analyzing data throughout the design and manufacturing process using process validation is extremely valuable to our customers.
We begin process validation with operational qualifications (OQ), such as whether we’ll need new equipment or must modify existing equipment to manufacture the product.
From there, our engineering and operations teams collaborate to create sample plans, determine what we’ll run on our press, and ensure everything is correct, from speed setting to material size.
Next, we experiment until we create a reliable product, which then undergoes process testing and inspections.
After OQ, we will finalize all drawings, work instructions, and press settings that we need to manufacture the product.
The next step is process qualification, in which we conduct trial runs.
During this phase, the operators use our documentation to set up the press and ensure the product is consistent.
This process is valuable for our customers because we both understand what our customers need for testing and samples and because we provide proper documentation throughout the entire process.
Documentation provides traceability through all phases.
This is useful if our customers are audited or need to investigate their product or track critical information.
Our process ensures we can trace the process back to raw materials, or even individual batches or subsets.
We know exactly where each material was used in the process and where it ended up.
Tapecon’s minimum documentation includes where each raw material was used in a product.
Depending on the industry, Tapecon follows many different compliance regulations including the ISO 9001 quality management systems; ITAR, for classified materials; Part 820 and 11 and CGMP from U.S. Food and Drug Administration; 13485 for medical devices; REACH for chemicals; ROJAS, for sustainability initiatives; and ASTM for performance specifications.
Our quality testing services include measurements, pool testing, and 100% visual inspection of everything, either with a human eye or a camera system.
Tapecon uses a holistic approach, in which our quality control is integrated throughout all of our company’s processes.
We understand how crucial it is that everything works correctly and for its intended use.
This meaningful work adds value to people’s lives and ensures important products, such as medical devices, work correctly when they need them.