Compliance & Risk
Manage Manufacturing Compliance and Quality Risk
Customer audits, recalls, and undetected process drift all carry the same risk: quality issues you can’t prove you caught in time. SynergySPC gives your team the electronic records, traceability, and reporting to manage that risk before it becomes a bigger problem.
Risk Hides in Undetected Variation
Quality risk arises when you can’t prove your process was in control, when paper records are slow to search, and when supplier issues go undetected.
- Customer or regulatory audits require fast, accurate access to historical process data.
- Recalls, returns, or supplier nonconformance often originate in variation that isn't caught in time.
Documentation Your Team Can Trust
SynergySPC replaces paper-based records with electronic data collection, constant monitoring, and role-based security, so your team can show a customer or auditor exactly how a process performed at any time. Synergy 2000 and Synergy 3000 include the access and security controls needed for FDA 21 CFR Part 11 compliance in regulated environments.
- Capability and traceability reports are ready whenever a customer or auditor requests them, without a special data-gathering effort.
Real-Time Proof
Grakon, a global manufacturer of vehicle lighting systems and engineered trim components, uses Synergy 3000 to meet strict customer quality requirements across its global plants. Grakon’s customers require a defective PPM rate below 50 (and, in some cases, below 15), and the team follows Automotive Industry Action Group capability standards with an internal Cpk goal above 2.
Cpk > 2
Internal Capability Goal
“ The SynergySPC software has really helped us with quality system compliance and continuous improvement ”
Don Bartlett, Director Quality & Customer Service for Grakon LLC
SPC Readiness Quiz
Not Sure Where Your Process Stands?
Take our quick self-assessment to see how your current quality control process compares and get a customized report on where to improve.
SPC Readiness Quiz
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