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With insufficient root cause analysis causing so many headaches to standards boards, certification bodies and certification applicants alike, it pays to spend some time evaluating the nonconformances that could lead to insufficient root cause analysis.

At the assessment level major and minor nonconformances have been identified as follows:

MAJOR

The nonconformance has reduced the capacity of the Quality Management System (QMS) to control processes or compliant products or services
Example: nonconformances perpetuated throughout the process, production halted, late delivery
The nonconformances are detrimental to the integrity of the product or service
Example: Discovery of counterfeit or suspect parts too late for recovery
Nonconforming goods have been shipped
Example: revised designs or processes fail to reach production in time to make the necessary changes
The nonconformance has resulted in failure or reduced use of the product or service for its intended purpose
Example: Contract changes reaching design and production too late to implement production changes

MINOR
No failure of QMS or control of processes
Single system failure or lapse (depending on criticality)

These examples are just the tip of the iceberg. Fortunately, the Qualidoc Internal Audit Checklist will help to reduce the risk of insufficient root cause analysis. It is available on the Qualidoc website.

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