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 ...

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!

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 - …

Mar 19, 2007 · Will it be classify as internal records (‘cause the template is from internal) or external records (‘cause the records or data comes from outside sources or external parties. So, it does not suggest despite the fact that the template used comes from ourcompany (internal), this record will be classify as external).

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.

Sep 25, 2018 · 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.

Feb 4, 2005 · I just had a customer ask us to change our Certificate of Conformance to a Certificate of Compliance. This is a typical type of document that is quite commonly included with a shipment of product. Apparently there is thinking within their quality department that the term compliance is more...

Feb 14, 2008 · Re: New Member Welcome to The Cove! :big wave: In my view, a form is a document used to record something. A record is the completed form.