Engr

Problem Statement

Biometric Flex Inc., a biomedical company specializing in the advanced manufacturing of the Biopsy FLEX (21G) retractable needle, has announced a voluntary global medical device removal of this product.

The company has requested that customers quarantine all affected devices from lots AX220 through AX249 manufactured prior to January 26, 2026.

This action follows several complaint reports received from five end-user customers located in Europe and Asia.

Healthcare personnel are advised to ensure that products from the affected lots are not used and to follow the manufacturers instructions regarding the removal process.

The issue has adversely affected 18 patients worldwide. In these cases, the needle dislodged inside the patients body due to a poorly welded area that did not meet customer specifications (tolerance requirement: 1.5 mm to 2.5 mm).

The estimated financial impact on the company is approximately $23.5 billion due to this major product nonconformance.

The nonconformance has been classified under a Form defect, as it affected the proper functioning of the product during advanced surgical procedures.

During the initial Design phase, it was determined for following critical dimensions:

Biopsy samples are inadequate when needle length is below 1.5mm

Biopsy Needles Weld fails and needle is retracted beyond 2.5mm

Answer these questions:

Where did problem occur?

When did the problem occur identified?

What process did the problem involve? (What is FailureMode?)

How is the problem measured?

How much is the problem costing? (In money, time. Customer satisfaction, or

another critical metric which can include Safety of employees, Line-down,

Repeated issue, one-off)

Success Criteria: Describe what should be idle condition for a good product.

You can use one or all factors of CE!

Define Phase

Specify what is original tolerance level specified for this biopsy needle.

What is the design average ?

Calculate appropriate process standard deviation if VoC aligned with VoP

Calculate 3-Sigma process level

Slide 5

The quantity of 110 units of biopsy needle was sampled from the recalled lots and data was collected.

Find the average and standard deviation of the failed sample.

Is the data acceptable?

What percentage of defects are observed in 110 units above?

What sigma level is the failed lot falling under?

How many units are non-conforming beyond the tolerance level?