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Mary Sennett, Tapecon’s Quality and Compliance Manager, has been with the company for nine years.
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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.
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Tapecon uses a similar “best practices” validation process across all industries, although some steps vary due to a product’s intended use.
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We always use specific, appropriate steps for every product or component.
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Documenting and analyzing data throughout the design and manufacturing process using process validation is extremely valuable to our customers.
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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.
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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.
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Next, we experiment until we create a reliable product, which then undergoes process testing and inspections.
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After OQ, we will finalize all drawings, work instructions, and press settings that we need to manufacture the product.
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The next step is process qualification, in which we conduct trial runs.
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During this phase, the operators use our documentation to set up the press and ensure the product is consistent.
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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.
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Documentation provides traceability through all phases.
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This is useful if our customers are audited or need to investigate their product or track critical information.
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Our process ensures we can trace the process back to raw materials, or even individual batches or subsets.
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We know exactly where each material was used in the process and where it ended up.
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Tapecon’s minimum documentation includes where each raw material was used in a product.
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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.
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Our quality testing services include measurements, pool testing, and 100% visual inspection of everything, either with a human eye or a camera system.
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Tapecon uses a holistic approach, in which our quality control is integrated throughout all of our company’s processes.
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We understand how crucial it is that everything works correctly and for its intended use.
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This meaningful work adds value to people’s lives and ensures important products, such as medical devices, work correctly when they need them.