Beyond the Tangible: Understanding Intangible Non-Conformances in QMS

Beyond the Tangible: Understanding Intangible Non-Conformances in QMS

A fundamental principle of any Quality Management System (QMS), especially those certified under ISO 9001, is having a robust system for identifying, containing, quarantining, analyzing, and addressing non-conformances to ensure continuous improvement.

It's human nature to default to the tangible. When asked about non-conformances, our minds often go to defects or issues with physical inputs or outputs. Examples include missing or damaged part numbers in an incoming shipment, an in-process component being machined incorrectly, or a completed product with a noticeable scratch.

However, non-conformances are not limited to physical inputs and outputs within an organization. They can also be intangible or non-physical. To assist you in designing the non-conformance procedures of your QMS, here are 15 intangible inputs or outputs to consider:

1. System Failures: Malfunctions or breakdowns of software systems, IT infrastructure, or automated processes that impact operations. For example, a failure in the inventory management system leading to incorrect stock levels.
    
2. Incorrect Documentation: Errors in documentation that lead to misunderstandings or incorrect actions. For instance, a user manual with outdated instructions.
    
3. Deficient Documentation: Documentation lacking necessary details or clarity, making it difficult for users to follow. An example could be a maintenance procedure that does not specify required tools or safety precautions.
    
4. Missing Documentation: Required documentation not available, leading to gaps in information. For example, a missing quality control report.
    
5. Process Deviations: Instances where standard operating procedures are not followed, leading to potential risks or inefficiencies. For example, skipping a step in a quality check process.
    
6. Training Deficiencies: Situations where employees have not received adequate training, resulting in errors or non-compliance. For instance, new hires not being trained on safety protocols.
    
7. Communication Failures: Breakdowns in communication that lead to misunderstandings or missed actions. An example could be a failure to communicate changes in project requirements to all team members.
    
8. Data Integrity Issues: Problems with the accuracy, consistency, and reliability of data. For example, discrepancies in financial records.
    
9. Incorrect Stock Levels: Recorded stock levels not matching the actual physical inventory. For example, the system shows 100 units in stock, but only 90 units are physically available.
    
10. Mislabelling of Items: Items in the inventory are mislabeled, leading to confusion and potential errors in order fulfillment. For instance, a product labeled as "Part A" is actually "Part B".
     
11. Expired Stock: Inventory items that have passed their expiration date but are still recorded as available for use or sale. This is common in industries dealing with perishable goods.
     
12. Stock Discrepancies: Differences between the recorded stock and the actual stock due to theft, loss, or administrative errors. For example, missing items not accounted for during stocktaking.
     
13. Incorrect Stock Rotation: Failure to follow the First-In-First-Out (FIFO) or Last-In-First-Out (LIFO) principles, leading to older stock being left unused while newer stock is used first.
     
14. Unrecorded Stock Movements: Movements of stock not recorded in the inventory management system, leading to discrepancies. For instance, items moved from one location to another without updating the system.
     
15. Inaccurate Stocktaking Procedures: Errors in the stocktaking process itself, such as counting mistakes or failure to follow standard procedures. For example, double-counting items or missing certain sections of the warehouse.