EndoTech's Quality Assurance Management team monitors production from raw-material selection through final inspection. Our quality approach focuses on checking instruments against the applicable product requirements, identifying discrepancies and reviewing finished products before shipment.
Inspection is most useful when requirements are clear before production begins. EndoTech's published quality information describes checks at multiple production stages rather than relying only on a final visual review.
Dimensions, materials, finish and functional characteristics differ between instrument types. The inspection criteria should therefore follow the product specification and any agreed customer requirements.
A polished instrument can still have a dimensional or functional issue. Quality review should consider the relevant material, geometry, workmanship, movement and working-end characteristics for the specific instrument.
These are the main areas a product-specific inspection plan should cover. The checks used for a particular instrument depend on its design, specifications and intended function.
Review the received material against the specified grade, identification and condition. Where material documentation is required, it should be checked against the order or purchasing requirements.
Check defined lengths, working dimensions, jaw or tip configuration, alignment and other critical measurements using appropriate measuring equipment.
Review visible finish, surface condition, burrs, marks, alignment and workmanship against the product's acceptance criteria.
Where applicable, verify opening and closing, joint movement, locking action, jaw alignment, cutting performance or the relevant working-end function.
Compare the instrument with the approved specification or sample where one has been agreed for the order.
Review the finished instrument against applicable acceptance criteria before it is approved for packing and dispatch.
Dimensional checks help determine whether the inspected instrument matches its defined measurements and product requirements.
A dimensional inspection should be based on the product drawing, agreed specification or approved reference. The inspector needs to know which measurements are critical and what limits are acceptable.
Depending on the instrument, the inspection plan can include:
Buyers with an OEM specification should identify critical dimensions before sample approval. This gives both parties a clear reference for subsequent inspection.
Appearance, movement and working-end characteristics need to be reviewed according to the type of surgical instrument. A single generic test cannot replace product-specific criteria.
The surface and overall workmanship are checked against the instrument's required finish and acceptance criteria.
Moving parts and working ends require checks appropriate to their function and design.
Final inspection brings the relevant checks together before instruments are released for packing and dispatch.
Final inspection is the opportunity to verify that the finished instrument meets the applicable product and order requirements. The acceptance criteria should be established before inspection begins.
Packaging and shipment should follow the agreed order requirements after the required release checks are complete.
A credible quality process must address products that fail an inspection or do not match the agreed specification. The affected item should not be treated as conforming until the issue has been reviewed and resolved.
Record the nonconformity clearly, including the affected feature and the requirement that was not met.
Keep the affected product separate from approved product while an authorized person evaluates the issue.
Determine whether the item can be reworked, must be rejected or requires another documented disposition.
Where rework is authorized, inspect the affected feature again before the item is considered conforming.
Inspection is easier to understand when the product requirements are defined before the order is produced. This is particularly important for OEM buyers and repeat orders.
Share the requirements that will determine whether the instrument is acceptable.
Buyers can discuss which inspection reports, measurement results, material documents or other quality records are maintained and available for their products.
The available documentation depends on the product, order requirements and the records maintained under the applicable quality process.
Sensitive customer information and confidential product specifications should be removed before any example inspection record is shared publicly.
Buyers need to understand what is inspected, which requirements apply to their products, and what documentation is available before arranging a shipment.
For U.S. and international sourcing, agree on critical dimensions, working-end requirements, materials, finishes and any product-specific acceptance criteria during the quotation and technical review stage.
Where a buyer requires a particular report or record, it should be discussed before production so availability and requirements can be confirmed.
For regulatory and certificate questions, visit the Certifications & Compliance page and request current documentation relevant to the product and destination market.
Send your product list, reference instruments, drawings, quantities and inspection requirements. EndoTech can review the information and discuss the quality criteria applicable to the proposed order.
Answers to common buyer questions about surgical instrument inspection and quality requirements.
Send EndoTech your product list, specifications, reference instruments and quality requirements. The team can review the request and discuss the applicable inspection criteria and available documentation for your order.