Incoming Inspection Records using Excel File

#1
Hello

We currently manually prepare the inspection results (ex. dimension, visual inspection, etc) at the inspection record. But there are so many results to prepare with handwriting.
So we are currently preparing the excel sheet to type the dimension results at the excel file. Once completed, excel file will be printed out for the final approval and signature.
Is there any risk for doing incoming inspection like this? Please give advice.
 
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somashekar

Staff member
Super Moderator
#2
Hello

We currently manually prepare the inspection results (ex. dimension, visual inspection, etc) at the inspection record. But there are so many results to prepare with handwriting.
So we are currently preparing the excel sheet to type the dimension results at the excel file. Once completed, excel file will be printed out for the final approval and signature.
Is there any risk for doing incoming inspection like this? Please give advice.
Its fine as long as it is meeting your requirements of verification of purchased products. Pay attention to how your signed excel inspection report meets the requirements of control of records (4.2.5)
If you are capturing any measurements from instrument, make sure you note that instrument ID which is coming from your calibration process. Capture the identify of the person approving the records, and make sure his authority for such approving is documented as in Responsibility and authority (5.5.1).
Juat a bit of process interactions in verification of purchased products.....you are good :agree:
 

Tidge

Trusted Information Resource
#3
Hello

We currently manually prepare the inspection results (ex. dimension, visual inspection, etc) at the inspection record. But there are so many results to prepare with handwriting.
So we are currently preparing the excel sheet to type the dimension results at the excel file. Once completed, excel file will be printed out for the final approval and signature.
Is there any risk for doing incoming inspection like this? Please give advice.
You will be facing the typical risks relating to the authenticity and integrity of the recorded data, just as if the records were originally committed to paper. Is the person signing the printout attesting that the data on the sheet is the data they measured? (the question is somewhat rhetorical, the point I am trying to make is that people in regulated industries need to be aware of the meaning of their signature)

With the addition of the step of "printing from Excel" (prior to signing) there are potential issues independent of authenticity and integrity:
  • Excel applies formatting to data; you probably want to ensure that the Excel is behaving as close to a "typewriter" as possible (search for 'typewriter rule')
  • The page (size, orientation) layout, column widths, etc. should be fixed so that no data is lost/obscured because it is off the page, hidden in margins, etc.
Using Excel in this way will raise eyebrows on different fronts. For example... can the data entry person "walk away" from the data sheet, either by physically closing the sheet, walking away from the workstation, minimizing the application, etc.? I suspect you want to avoid all appearances of keeping 'electronic records'.
 
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