Categorizing Observations & Non-conformities

Conformance – complies with the requirements of the process, no actions required

Scope for improvement – an aspect of either the project or process that could be improved, usually does not directly affect the quality of the project but can improve efficiency or effectiveness

Observation – minor issues against the process that should be corrected but may not directly affect the quality of the product

Nonconformance – areas that fail to comply with the SDLC and supporting processes and working practices or that fail to comply with the standards ISO9001, TickIT Guide 5 etc and therefore directly affect the quality of the product

 

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e.g.

 

Observation is something which would turn into a non-conformance if you wouldn't take preventive action.

Non-conformance is deviation from the paln, which you said in the plan that you are going to do and you didn't do.
ex: In the plan you documented that you would peer review all the design documents but you failed to do a peer review for one of the design docs ...thats a non-conformance.

In the plan you documented that you would unit test all the code , but the at the time of audit it is observed that the team doesn't have enough time to unit test all the code and you are planning on unit testing high risk modules....this is an observation, which might turn into a non-conformance if don't address the time issue.

Observation is something which would turn into a non-conformance if you wouldn't take preventive action.

Non-conformance is deviation from the paln, which you said in the plan that you are going to do and you didn't do.
ex: In the plan you documented that you would peer review all the design documents but you failed to do a peer review for one of the design docs ...thats a non-conformance.

In the plan you documented that you would unit test all the code , but the at the time of audit it is observed that the team doesn't have enough time to unit test all the code and you are planning on unit testing high risk modules....this is an observation, which might turn into a non-conformance if don't address the time issue.

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Diff	Nonconformity	Observation
Isolated Nonconformance	N	Y
Not a Clear Cut Nonconformance	N	Y
Systemic Nonconformance	N	Y
Newly Implemented System	N	Y
Not a Enough Data for A Nonconformance	N	Y
Recommendation?	N	Y
Ineffective System?	N	Y
Nonconformance is Hearsay	N	Y