Whether your application requires a pressure-sensitive label or an FDA-compliant disposable medical device, one thing in every project is true: a commitment to quality makes a difference in the end product.
It’s an easy sentence to type but a difficult concept to achieve. Here at ATL, we live that commitment every single day by consistently taking a Six Sigma approach in accordance with a number of standards and regulations, including ISO-13485, MDD 93/42/EEC and FDA cGMP.
These protocols, which involve a variety of elements, always begin with the same steps:
Formulate product development by identifying customer needs from a variety of perspectives, including:
- Stated customer requirements (the intended use of the product)
- The Six-Sigma approach of DMAIC - Define, Measure, Analyze, Improve, Control
- APQP (Advanced Product Quality Planning)
Define and Implement process development from the customer's design goals by determining:
- Necessary materials
- Process flow
- Timeline for completion
- ATL roles and responsibilities
- Feasibilities of the proposed product as ranked by manufacturability (cost effectiveness)
- Feasibilities of the proposed product as ranked by potential product hazards to the end user (FMEA or ISO-14971 Risk Analysis)
Measure, Analyze, Improve, and Controlthe manufacturing process by:
- Understanding the critical to quality characteristics (CTQ’s) required by the client
- Determining process stability
- Determining process capability
- Determining packaging standards
Develop the client's product control plan or FDA cGMP Performance Qualification (PQ), which covers:
- Characteristics class
- Specification tolerances
- Measurement technique
- Cpk determination
- Sample size
- Sample frequency
- Control method
- Reaction plan
The process is time consuming and detail oriented but always attempts to achieve this final goal: the best product for the client made the best way with the best materials.
Click here to view a PowerPoint providing more details on our system validation protocolsand, when quality is paramount, make sure to contact ATL for assistance with your disposable medical device or pressure-sensitive label.