QA & QC SERVICES

Quality Assurance & Quality Control (QA & QC) Services

In today’s hyper-regulated industrial landscape, consistent product quality is no longer a competitive advantage—it is the price of admission. Whether you manufacture sterile injectables, turbine blades, or bridge cables, every lot must conform to unforgiving specifications, withstand third-party audits, and perform flawlessly in service. Yet variability lurks in raw materials, process settings, human factors, and environmental conditions. Left unchecked, these deviations translate into scrap, recalls, and reputational damage.

Quality Calibration Solutions (QCS) provides end-to-end Quality Assurance & Quality Control (QA & QC) Services that embed rigor into every phase of your value chain. Combining ISO 9001-certified methodologies, Six Sigma analytics, and sector-specific standards such as cGMP, AS9100, API Q1, and EN 1090, we safeguard your brand, protect end-users, and unlock operational excellence.

 
 

 

 

Why QA & QC Matter?

A single out-of-tolerance dimension, mis-identified alloy, or undocumented parameter shift can cascade into systemic failures—contaminated batches, premature fatigue, catastrophic field events. Effective QA & QC programs serve as a multilayered defence system:

  • Preventive: By validating suppliers, processes, and documents before production begins, QA averts defects at the source.
  • Detective: Through calibrated gauges, in-process inspections, and statistical sampling, QC intercepts non-conforming units before they leave the plant.
  • Corrective: Root-cause analysis and CAPA (Corrective and Preventive Action) close the loop, hardening processes against recurrence.

Robust QA & QC are therefore strategic investments that reduce warranty claims, lower cost of poor quality (COPQ), shorten regulatory approval cycles, and fortify market credibility.

Key Elements of Our QA & QC Services

1. Quality Management System (QMS) Audits
We benchmark your QMS against ISO 9001, IATF 16949, ASME NQA-1, or client-specific criteria. Using process mapping, turtle diagrams, and risk-based thinking, our lead auditors identify compliance gaps, maturity levels, and quick-win improvements. Deliverables include a prioritized action matrix and audit-ready documentation templates.

2. Supplier Qualification & Surveillance
Upstream quality sets the ceiling for downstream performance. Our auditors perform on-site supplier assessments—covering capacity studies, PFMEA reviews, material traceability, and change-control protocols. Real-time dashboards flag emerging risks, while scorecards drive continuous supplier development.

3. Process Capability & Statistical Control
 Using MSA-verified gauges and SPC software, we establish baseline Cp/Cpk values, design control charts, and implement automated alarms. For special processes—welding, heat treatment, sterilization—we validate critical parameters per CQI-9, AMS 2750, or ISO 11135, ensuring repeatability and reproducibility.

4. Material Verification & Positive Material Identification (PMI)
 Through XRF, OES, FTIR, and DSC techniques, we confirm incoming alloys, polymers, and pharmaceuticals match the bill of materials. Certificates of Analysis (CoA) are cross-checked against ASTM, USP, or ISO grades, eliminating the risk of counterfeit or sub-spec materials entering production.

5. In-Process Inspection & Test Plans (ITPs)
 We design and execute ITPs that embed inspection gates at receiving, first-article, patrol, and final stages. Vision systems, CMMs, torque transducers, ultrasonic flaw detectors, and microbiological assays are all calibrated to ISO 17025, guaranteeing measurement confidence.

6. Final Release Inspection & Functional Testing
 Prior to dispatch, each batch or asset undergoes a release protocol aligned with client specs, regulatory dossiers, and critical-to-quality (CTQ) attributes. Functional tests—pressure cycling, electrical continuity, sterility, load trials—simulate real-world stresses, ensuring product integrity in service.

7. Documentation, Traceability & Digital Lot Genealogy
 We deploy eDHR (electronic Device History Record) systems and blockchain-secured ledgers to link every serial number to its material heats, machine settings, and inspector credentials. This granular traceability accelerates root-cause investigations and satisfies regulators such as FDA 21 CFR Part 11.

8. Non-Conformance Management & CAPA
 When deviations arise, our cross-functional team performs 8D or A3 analyses, quantifies risk via FMEA, and recommends corrective actions—tooling redesign, operator retraining, gage R&R, or supplier requalification. Verified effectiveness checks lock in the gains.

Regulatory Compliance & Industry Standards

Our QA & QC methodologies align with, and often exceed, the world’s most stringent codes:

 
 

 

 

cGMP / EU Annex 1 for sterile pharma & biotech
API Spec Q1 / Q2 for oil & gas equipment
AS9102 first-article inspection for aerospace
ISO 13485 for medical devices
ASME BPVC Section III & V for pressure vessels and NDT
EN 1090 & ISO 3834 for structural steel fabrication

QCS provides fully referenced inspection plans, calibration certificates traceable to ILAC-MRA labs, and signed conformity declarations—keeping you audit-ready for FDA, EMA, OSHA, or notified bodies.

 
 

 

 

Preventive Approach & Continuous Improvement

Quality is dynamic; complacency breeds drift. Our service packages therefore bundle periodic surveillance audits, control-plan reviews, and gauge recalibration schedules. Using trend analytics and Pareto charts, we pre-empt capability erosion, translate data into actionable insights, and embed a culture of relentless improvement.

 
 

 

 

Customized QA & QC Programs

No two factories, rigs, or laboratories share identical risk profiles. QCS tailors its QA & QC blueprints to your product mix, regulatory exposure, and takt-time constraints. Whether you require pharmaceutical validation reports, aerospace FAIR books, or automotive PPAP submissions, we configure procedures, sampling plans, and acceptance criteria to fit your realities—not generic templates.

Advanced Analytics & Skilled Auditors

Our Certified Quality Engineers (CQE) and ASQ-certified auditors leverage:

  • Portable CMMs & laser trackers for large-scale geometries
  • Inline spectrometers & high-speed vision AI for 100 % inspection
  • Minitab® & JMP® for DOE, regression, and Monte Carlo simulations
  • E-QMS platforms with automated deviation workflows and KPI dashboards

Continuous upskilling, OEM training, and cross-industry exposure equip our team to spot latent defects others miss and to recommend process innovations that deliver sustainable ROI.

Ensuring Long-Term Value & Performance

Investing in professional QA & QC services delivers dividends far beyond defect reduction:

  • Lower Total Cost of Ownership – fewer reworks, leaner inventories, and smoother production flow.
  • Accelerated Market Access – compliant documentation expedites certifications and customer approvals.
  • Brand Protection – demonstrable quality culture builds client trust and premium positioning.
  • Operational Resilience – data-driven insights empower proactive maintenance and capacity planning.

In an era where social media can amplify a single defect into a global crisis, robust QA & QC is your reputational firewall.

Partner with Quality Calibration Solutions

At QCS, we view quality not as a department but as an ecosystem that spans suppliers, processes, people, and products. Our QA & QC Services integrate seamlessly with our Calibration, Inspection, Testing, and Training offerings, giving you a single accountable partner from raw material receipt to final shipment.

From kickoff gap analysis to final validation dossier, every deliverable is crafted with the same meticulous attention to detail that defined our tower-crane calibration success. Comprehensive checklists, photographic evidence, and digital signatures provide an unbroken chain of credibility that withstands the toughest auditors.

Contact Quality Calibration Solutions today to elevate your quality maturity, de-risk your supply chain, and embed a culture of excellence that endures. Let us help you deliver defect-free products, on time and in full—every time.