Quality

Quality is Built In.

EPTAM utilizes a completely seamless electronic Quality Management System (eQMS) that ensures high quality of everything we do for you. Our system is designed and validated to enable us to meet our customers’ design/manufacturing transfers (New Product Introduction – NPI), manufacturing quality assurance, supplier management and regulatory compliance requirements.

Precision Starts Before Production.

How we bring your program in determines how reliably we deliver. Requirements get reviewed. Risks get identified.
Supply chains get qualified. The work begins before the first part is ever made — because that’s where rhythm is built.

Feasibility Analysis

Confirming that EPTAM can reliably provide the customer with an end-to-end manufacturing solution

Contract Review

Performing an in-depth, cross-functional review ensuring that all project risks have been identified and mitigated

Supplier Quality Management

Assuring that every aspect of our supply chain has been audited and approved

Process Validation

We perform Installation Qualification on all equipment and where there are special processes and/or per customer requirements, Operational and Performance Qualification are executed using our SOPs or providing data in customer specific templates

Metrology and Inspection Analysis

Ensuring that all critical variables and attributes have been identified, and that all Gauge Study requirements have been met

Employee Training

Ensuring that EPTAM employees have received the training and certificates required for them to perform their assigned tasks

Manufacturing Transfer

Critical to providing a holistic contract manufacturing solution is ensuring that the product design has been appropriately
transferred to EPTAM. We maintain a comprehensive Device Master Record (DMR) “checklist” process confirming transfer of:

Prints and Specifications
Process Validation and Documentation
Measurement Systems
Incoming, In-Process and Outgoing QC Requirements
Contact Materials List
Supplier Management Requirements
Required Certification/Release Documentation

Precision isn't a moment.

Quality isn’t created at inspection. It’s built long before the part is made — in the process controls, the handoffs, and the ownership that keeps work moving at every stage. Reliability requires a rhythm, and that rhythm runs through everything we do.

Production Quality Control (QC)

In addition to meeting all customer-specified QC requirements, we conduct a thorough analysis to determine the appropriate quality control program. Tools employed include:

Process Failure Mode Effects Analysis (PFMEA)

Supplier 
Assessment

Quality Control Inspection Forms

Control Plan Development

Quality Compliance

Our eQMS allows us to maintain high level of quality compliance and to perform all issue investigation and communicates across all modules to enable thorough root cause identification and fast response to any issues:

Regulatory Compliance

As a Medical Device solution provider, we actively support all customer regulatory/approval activities, supporting global filings and compliance efforts. These include:

Features of Our QMS

Our Quality Management System is implemented to improve overall speed and efficiency. In addition to providing operational alignment to safety, quality, delivery, cost and innovation goals features of our QMS include:

Electronic Document Management
Electronic NPI Management
Electronic Records Retention
LMS Training Management
Electronic Issue Evaluation and Management
Version control of all documents (full DMR of each product, and eDocument Control)

Managed tool status
Full traceability
Product tracking
Real-time status views
Phase-gate approach in New Product Introduction to commercialization
Full FDA Facilities Registration (sites manufacturing finished medical devices), and ISO-13485:2016 and AS9100D:2015 certifications

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