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Malformed

This example lists the nonconformance name, its location, classification, definition and a photo or drawing. The photos or drawings are shown for illustration purposes only and do not represent limits for acceptance or rejection.

Content and text according PDA Glass Task Force - 2007.

Visual nonconformance

  • Name: Malformed
  • Location: Finish
  • Class: Critical is seal is compromised; Major B if seal is in tact.

Critical classification of nonconformance: Nonconformities that may result in personal injury or potential hazard to the patient. This classification is assigned to any nonconformity that compromises the integrity of the container, and risks microbiological contamination of a sterile product.

Major B classification of nonconformance: Nonconformities leading to impairments of a lesser degree, for example, reduced efficiency in production.

Example:

Example of Malformed defect

Description

Finish is glossy distorted or deformed.

Points to Consider

  • The Term “None-Allowed” should be attributed to those nonconformities that may arise out of a glassmanufacturer’s process or a non-process related error that is not sampled or estimated statistically and therefore should not be assigned an AQL.
  • Nonconformities should be reviewed and classified (with rationale) using a quality risk management approach.
  • Verification of nonconformity classifications may warrant additional testing to establish the irrationale.
  • A Limit Sample is a single container example that represents the maximum degree of acceptability of a nonconformance.

Acknowledgements

The photos or drawings are shown for illustration purposes only and do not represent limits for acceptance or rejection. Please take notice of the Acknowledgements