Some internal auditors may find it difficult to categorize their audit findings as NCR or Observation (Pemerhatian) as there are some grey-areas involved. This is quite common among inexperienced internal auditors.
NCR is short for Non-Conformance Reports (Ketidakpatuhan / Penyimpangan). The following are some tips that may be used as guidelines to differentiate between NCR and Observations :
An NCR
1. adversely affect safety as related to products, persons or property;
2. impact the usability of a product, performance of a service, or the integrity of the quality system;
3. significantly increase product cost;
4. potentially affect the ability to meet the customer’s requirements. Examples: incorrect process parameters, missing inspections or processing steps, failure to record required data, missed or out-of-tolerance calibration
5. result from failure to implement a corrective action from the previous audit.
6. Violated the ISO9001 requirements.
An OBSERVATION is defined as a statement of fact made during an audit and substantiated by objective evidence and auditor’s informational comments based on an assessment of a special process or quality system.
It is a non-systemic, isolated NCR that does not :
1. adversely affect the usability of a product, performance of a service, or the integrity of the quality system;
2. affect any product or process output. Example: paperwork oversights, minor changes to procedures for clarification.
Whether it is NCR/Observation, it must be for the sole purpose of CORRECTIVE ACTION (penambahbaikan) & nothing else ... ;)
Reference: http://elsmar.com/Forums/showthread.php?t=38090
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