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Non-Conformance
Non-Conformance in the industry refers to instances where a product, process, or service fails to meet specified standards, requirements, or expectations. These deviations can occur in various stages, including production, quality control, or service delivery. Addressing non-conformances is crucial for maintaining quality, safety, and regulatory compliance.
Identification
- Non-conformances are identified during inspections, audits, testing, or customer feedback.
- They can involve defects, deviations from specifications, or non-compliance with regulatory standards.
Documentation
- Each non-conformance is documented, often in a Non-Conformance Report (NCR), detailing the nature of the issue, its impact, and potential causes.
- Proper documentation is essential for tracking and resolving the issue.
Root Cause Analysis:
- Identifying the underlying cause of the non-conformance is critical for preventing recurrence.
- Techniques like the "5 Whys" or fishbone diagrams are commonly used for this purpose.
Corrective and Preventive Actions (CAPA)
- Once the root cause is identified, corrective actions are taken to fix the issue.
- Preventive actions are also implemented to ensure that similar non-conformances do not occur in the future.
Review and Closure
- The effectiveness of the corrective actions is reviewed, and the non-conformance is closed once the issue is resolved.
- Documentation is updated to reflect the resolution and any changes to processes or procedures.
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