2 replies to this topic

[connieb]

Hi all, I created the attached draft document to capture non conformances and corrective and preventative actions. Once the document is complete, it will be saved in pdf form as a record with a unique ID number.  This proposed document will be housed in the  Corrective Actions Room in Microsoft Teams and team members will be able to fill out the reports in Teams. In the current state of our program, we only save pertinent information in a log. I don't think a log is robust enough. To some, my proposed reporting system may seem archaic, but it would be an improvement of the current state of things at my company. Also, this form is just a snippet of what I hope to do for value add at my current employer. Feel free to adopt this form for your own use if you see some value in it. Thanks in advance for your feedback.

Attached Files

•  DRAFT_Non-Conformance CAPA Report.xlsx   39.99KB   232 downloads

[Charles.C]

Hi all,

 

I created the attached draft document to capture non conformances and corrective and preventative actions. Once the document is complete, it will be saved in pdf form as a record with a unique ID number.  This proposed document will be housed in the  Corrective Actions Room in Microsoft Teams and team members will be able to fill out the reports in Teams. In the current state of our program, we only save pertinent information in a log. I don't think a log is robust enough. To some, my proposed reporting system may seem archaic, but it would be an improvement of the current state of things at my company. Also, this form is just a snippet of what I hope to do for value add at my current employer.

 

Feel free to adopt this form for your own use if you see some value in it.

 

Thanks in advance for your feedback.

 

Hi Connie,

 

Thks for the draft. A few random thoughts -

 

Layout Format is often a Personal Choice.

"Preventative" probably really is archaic ?.

"Report Type" - Over-intricate IMO. I suggest you need 4 boxes for some clarity.

What is difference between corrective and preventative action ? Do users of form know ?

What does "responsible function" mean ?

"OWNER" is rather ambiguous/foreboding. In practice, will QA complete ??

"ORIGINATOR" will in practice  always be QA therefore redundant ?

"Disposition" has insufficient Scope, eg PRP defects (unless such are handled elsewhere). (Scope of the Form itself ??)

"CAPA" is I suspect strictly Americanese.

"Root Cause of problem" is I think (Eng) Globally written as "Root Cause Analysis" (RCA)

"Opportunity for Improvement" is a potential "Pandora's Box" IMO. Specific Audit terminology ? Really required (here)?

"Follow-up" similar comment to previous. I suggest QA co-signature is sufficient.

No.2 Not obvious what the Signature(s) corresponds to.

 

I guess I find the form a little over-elaborate. OK if the users understand/are happy with it though. Less sure for an Auditor.

[connieb]

Hi Connie,

 

Thks for the draft. A few random thoughts -

 

Layout Format is often a Personal Choice.

"Preventative" probably really is archaic ?.

"Report Type" - Over-intricate IMO. I suggest you need 4 boxes for some clarity.

What is difference between corrective and preventative action ? Do users of form know ?

What does "responsible function" mean ?

"OWNER" is rather ambiguous/foreboding. In practice, will QA complete ??

"ORIGINATOR" will in practice  always be QA therefore redundant ?

"Disposition" has insufficient Scope, eg PRP defects (unless such are handled elsewhere). (Scope of the Form itself ??)

"CAPA" is I suspect strictly Americanese.

"Root Cause of problem" is I think (Eng) Globally written as "Root Cause Analysis" (RCA)

"Opportunity for Improvement" is a potential "Pandora's Box" IMO. Specific Audit terminology ? Really required (here)?

"Follow-up" similar comment to previous. I suggest QA co-signature is sufficient.

No.2 Not obvious what the Signature(s) corresponds to.

 

I guess I find the form a little over-elaborate. OK if the users understand/are happy with it though. Less sure for an Auditor.

 Some of the verbiage I used is based on what already existed as part of the plant's lexicon. Thank you for pointing out areas of improvement for this document.