Failure Analysis Investigation Points to QC Solution to Maintain Profits and Customers


Client Challenge

Shatter-prone glass syringes pose any number of risks — to patients and health care workers — and costly, potentially dangerous waste. One well-known medical device manufacturer wanted reliable data on why syringes from an overseas manufacturer would shatter upon loading.

RJ Lee Group Approach

Our team examined failed and unused syringes, and reconstructed a failed syringe, which had shattered into several hundred spiral-shaped shards.

Our microscopic examination revealed the gross pattern of failure, and the location of failure origin. A more detailed microscopic examination of that spot revealed forming defects — the glass had not completely formed and healed during the rolling process, resulting in a weak point that ultimately caused the failure.

Outcome

Data translated to corrective action — a meeting of the minds between the supplier and medical device maker, with RJ Lee Group’s report used to illustrate the failure. The material failure analysis showed that folds developing during the glass forming process generated the defects in the syringes. As a result, RJ Lee Group included the following suggestions for corrective action: (1) increase the process temperature, (2) slow down the process, or (3) flame polish the item at the conclusion of the process to strengthen the glass.

RJ Lee Group continues to be involved in providing subsequent quality assurance and quality control services for this medical device manufacturer.