Most non-conformities in medical device manufacturing are not caused by design flaws, but by uncontrolled changes.
Even in validated, stable production environments, small changes to people, equipment, materials, processes, or inspection systems can introduce variability that compromises product quality, regulatory compliance, and patient safety. This is why change control is a foundational requirement under ISO 13485 and FDA Quality System Regulations.
At Sanbor Medical, change is treated as a regulated input. Through a structured, ISO 13485-aligned change management system, every change is formally identified, risk-assessed, approved, validated, and documented. This ensures consistent quality and audit readiness.
A change point is any alteration that can affect:
Product characteristics
Process capability
Compliance status
Inspection results
Patient safety risk
Change points are commonly categorized using the 5M1E framework:
Man – People and training
Machine – Equipment, tooling, and software
Material – Components, raw materials, and consumables
Method – Processes, work instructions, and inspections
Environment – Facility and operating conditions
Measurement – Inspection and test systems
When changes occur without proper change control, validation, and documentation, the result is increased non-conformities, rework, scrap, customer complaints, and regulatory exposure.
Sanbor Medical’s Quality Management System is designed to identify and control change points before they become quality failures.
Personnel changes are one of the most common sources of unintended process variation.
Common people-related change points include:
New employee onboarding
Job rotation or coverage substitutions
Return from extended leave
Deviation from standard work practices
Sanbor Medical controls personnel changes through:
Pre-change risk assessment
Documented training and qualification
Personnel qualification matrices for critical roles
In-process monitoring and post-change verification
This ensures only qualified, trained personnel perform regulated operations. This reduces human-driven variability and protects validated processes.
Changes to production equipment, tooling, fixtures, automation, or software directly impact process validation and product quality.
Machine-related change points include:
Preventive and corrective maintenance
Equipment relocation or replacement
Mold and fixture changes
Software and automation updates
Adjustments to critical process parameters
Sanbor Medical applies formal equipment change control and re-validation protocols, including:
Change request and risk assessment
Controlled implementation
First Article Inspection (FAI)
Post-change validation and documented release
Any equipment that is repaired, replaced, relocated, or restarted is treated as a new validated condition—protecting process capability and compliance.
Material changes are among the highest-risk quality variables in medical device manufacturing.
Common material change points include:
New or alternate suppliers
New material batches (especially first lots）
Engineering specification changes
Approved substitute materials
Packaging, storage, or logistics changes
Sanbor Medical manages material changes through:
Formal change approval and supplier control
Enhanced incoming inspection
Critical characteristic testing
First article and small-lot validation
This prevents batch-to-batch variation from introducing hidden defects that lead to downstream non-conformities.
“Method” includes all documented processes, work instructions, inspection methods, and control plans.
Method-related change points include:
Process flow changes
Parameter updates
Step consolidation or splitting
Inspection method changes
Sampling plan adjustments
Sanbor Medical enforces strict document and method control:
No changes without formal approval
No implementation without validation
No rollout without documented training
This ensures continuous improvement does not compromise regulatory compliance or process predictability.
Environmental conditions directly affect many medical device manufacturing processes.
Environmental change points include:
Cleanroom classification changes
Temperature and humidity variation
Electrostatic discharge (ESD) controls
Facility layout changes
Utility disruptions
Seasonal climate variation
Sanbor Medical actively monitors and controls environmental conditions for critical processes—ensuring environmental inputs remain within validated limits.
Changes to inspection and test systems directly affect acceptance decisions and regulatory records.
Measurement-related change points include:
New or replaced inspection equipment
Calibration deviations
Software updates
Inspection method changes
Acceptance criteria revisions
Inspector changes
Sanbor Medical requires Measurement System Analysis (MSA) and validation for all inspection system changes—ensuring data integrity, repeatability, and audit defensibility.
In regulated manufacturing, uncontrolled change is one of the leading root causes of:
Non-conformities
Batch failures
Regulatory findings
Customer complaints
Product recalls
Sanbor Medical’s change management system is built on three pillars:
Visibility – All changes are identified and documented
Control – All changes are risk-assessed, approved, and validated
Traceability – Full documentation supports FDA and ISO audits
By embedding change control into daily operations, Sanbor Medical helps OEMs:
Maintain validated process stability
Reduce non-conformities and quality escapes
Support FDA and ISO 13485 compliance
Enable controlled continuous improvement
This disciplined approach allows Sanbor Medical to transform operational change from a regulatory risk into a structured, compliant driver of long-term quality and operational excellence.
Contact us to learn more.
