Tracking ISO 9001 non-conformance issues is critical for maintaining quality management standards and ensuring continuous improvement in manufacturing. They identify deviations from established processes, enabling root cause analysis to prevent recurrence.
Below are some of the recent, recurring Non-Conformances we have seen over the past few month as we work with our clients.
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1. Lack of labelling of inspection status in production and shipping
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. (8.5.1d)
2. Maintenance activities are past due.
c) the use of suitable infrastructure and environment for the operation of processes (8.5.1c)
3. Machine maintenance record is not up to date. Systemic issue.
“7.1.3 Infrastructure . . . The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. . . infrastructure can include b) equipment .
4. Equipment adjusted after calibration (As found calibration data out of tolerance) requires a validity of previous inspection statement.
7.1.5.2 The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
5. Approved vendor evaluation records not up-to-date and records not retained
8.4.1 The organization shall determine and apply criteria for the evaluation, selection. of external providers based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.
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