Assessments

EVALUATIONS: FROM THE FACTORY FLOOR TO YOUR DESKTOP

SQA offers a wide range of audit and assessment services designed to give you the maximum amount of information about your suppliers. Our global network of associates, assess your suppliers’ capabilities on the ground to help you maintain a high-quality supply chain. We leverage 30 years of expertise to deliver comprehensive assessments using a curated suite of customized tools. Our secure, cloud-based platform, STEPQ, ensures seamless access to results for all stakeholders and can be tailored to your specific assessment needs.

Critical Manufacturing

SQA provides a range of assessments, including process and product evaluations, PPAP Readiness Assessments, Requirement Consumption Reviews, and AS9100/ISO9001 assessments. These services help ensure your suppliers meet your requirements, provide necessary pre-production documentation, and have the capability to produce specific parts using the required processes.

Life Sciences

We support regulatory audits and process-specific biologics audits executed by our team of subject matter experts. Our experienced network of industry professionals is equipped to evaluate suppliers for Biologics, Excipients, APIs, and medical devices, ensuring compliance with FDA, EU, and ISO standards. Additionally, SQA conducts gap assessments to help prepare for upcoming regulatory inspections.

Supplier Desktop Evaluation

SQA offers comprehensive supplier review without having to be on-site via the Supplier Desktop Evaluation (SDE) tool. SQA SDEs combine the qualitative aspects of secure, objective evidence gathering with the quantitative aspects of automated, tracked, and scored supplier evaluation criteria. Using STEPQ’s Activity Profiler tool, you can revise any checklist—scored or unscored.. We work collaboratively with you to optimize your SDE as part of the rollout process.

Once an SDE program is underway, SQA handles data collection, reviews supplier responses, and requests additional information as needed to ensure a complete and accurate assessment. SDEs are scalable, ranging from basic supplier data collection to full remote assessments by one of our certified lead auditors. During the scoping process, we work with you to determine the appropriate level of depth and oversight needed.

For Suppliers:

STEPQ’s intuitive interface helps suppliers quickly complete their information.
SQA’s Mobile Inspection Control and Capture System, or “MICCS”, within STEPQ, mitigates the risk of escapes during source inspection while driving efficiency.

For Clients:

Authorized users can track program status in real-time through SQA’s STEPQ interface, with automatic email notifications for required actions. Dynamic graphs highlight overall results immediately.
View supplier responses, objective evidence, score, and status.
Any subsequent action (e.g., corrective action) appears as a connected event, which follows its own process to closure (including separate supplier response).

Client Selection

Client selects supply partner for SDEs

Step 1

Client Request

Client requests SQA
perform SDE

Step 2

SQA Notification

SQA notifies Supplier of SDE

Step 3

SDE Completion

Supplier completes SDE in
STEPQ

Step 4

SQA Review

SQA reviews Supplier SDE
response

Step 5

Clarification

SQA and Supplier clarification

Step 6

Finalization

SDE finalized and Client notified

Step 7

Result

Satisfactory
Needs to Improve
Unsatisfactory

BY THE NUMBERS

300+ assessments globally for one client in one year