Jan 20, 2005 · Such organizations create a "template" upon which ALL documents are based (further divided into text templates, drawing templates, flow chart templates, etc.) Using the "template," an organization may create a "form" with spaces for data to be added to make a record of activity.

Jan 14, 2005 · The physical layout of the form (template) may be modified from time to time, but it still has to contain the same basic data or it is not serving the purpose. Large companies are rigid about the use of Forms because it helps assure uniformity of collection from data entry person to data entry person throughout the organization.

Nov 19, 2013 · Engineering Change order vs. Change Control duff999; Aug 26, 2021 ...

DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record Dear all coves Can some one explain by definition what is a difference between a DMR, DHF and DHR.

Aug 22, 2018 · Hello All, I would like to ask about root-cause analysis in 8D reports, namely if we have in D4 sections: root-cause for occurence & root-cause for non-detection and also to the 8D template is attached tab with 5Why to fulfill, and for instance this 5Why is resolved in full 5 steps - …

Oct 2, 2023 · Hi, With the recent US FDA release of the guidance "Content of Premarket Submission for Device Software Functions", does anyone know or have an updated version of the comparison of the software documentation elements between the FDA requirement and IEC 62304? Thanks!

Jun 25, 2002 · What's the difference... Hi Tomjess, To my opinion a quality alert is something in which you state that somethings wrong with the quality...but this hasn't have to be necessarily be a non-conformance of the product or process..It also can mean that you see potential problems...I recently changed this in our process...we now have a non-confomance report and a …

Jul 29, 2010 · Hi, Our system just practice 5D as for our Corrective Action record. Since most of the customer asking for 8D, should i remove 5D from the procedure and replace it with 8D or is it possible to have both? My boss is asking can it be both in the procedure since he want the 5D to be used internally.

Nov 19, 2009 · Re: Customer Audit - C.A.S.E. Standard 1-A vs. AS9110 - Aircraft Assemblies Maintenan Thank you for the clarification. I understand where you are coming from now and your frustration. So, as a manufacture (OEM) per the regulations you are entitled to …

Jun 11, 2001 · ISIR vs PPAP The term ISIR ( Initial Sample Inspection Report) is being used by Germany companies like VW and BMW. ISIR form is standardized by VDA. The term is also used by some other companies like Hyundai and Kia. In fact ISIR is like the Warrant and Inspection Report of PPAP document package.