Non Compliance report Template

TEMPLATES & PRESENTATIONS TEMPLATES
1

Please find the template attached of Non Compliance Report.
Its ready, Useful & Applicable.
This is generally attached to CAPA initiation form.
Regards

NCR.doc (42.5 KB)

2

Thanks Durga, nice upload.

3

Durga,

I appreciate you uploading the sample NCR form. Please take the following as not a criticism but in the spirit of “continuous improvement.” Some thoughts on the form:

  1. I recommend removing pretty much everything in the header. Too difficult to try to keep all that updated to the parent SOP version / effective date. There’s no reason why the form would have to change if the parent doc was updated.

  2. Categorizing as ‘major,’ etc. can be challenging. I recommend both a priority and a severity. That allows more flexibility in knowing what’s most important. For example if you have something that’s a low severity but high priority (e.g., a non-impacting typo on product labeling), is it major? Clearly it needs to be fixed ASAP but the fix is simple.

  3. This is, admittedly, a ‘nit’ but the ‘Details’ section should be details of the NC, not the NCR.

  4. The form implies that a corrective action and a preventive action is always required. That shouldn’t be the case. The disposition may well be “use as is” and the impact is so minimal that no further actions are warranted. Also note that ‘Disposition’ is a very common field in NC reports but not included here - I would highly recommend adding it.

  5. Regarding CAPAs, I would recommend having a means to indicate whether or not a CAPA should be opened (and provide linkage). This way, if one is opened, you have the appropriate linkage to the CAPA but if one is not required, you have shown that you considered it. Note that rationale for NOT doing a CAPA is pretty common.

  6. Were this actually used as the CAPA tracking, there’s no follow-up to ensure the actions are effective. Again, though, I would separate CAPA from this.

  7. The sections imply a site-specific flow (executive QA, head QA, head - operating dept, etc.). Probably should be pointed out that these should be adapted per organization. Regulations don’t specify who has to approve.

Hope this helps and/or spurs some good discussion over NCR content.

4

Thanks Yodon about the comments.
I certainly agree with the comments you posted and will look keenly into every detail.
Iam a staunch follower of “Kaizen” or Continuos improvement.
Your comments are valuable.
Regards