IEGeek said:
A studious engineer discovers while reviewing the SOP that the designer misspelled two words (calclaute & calpiers) so like a good engineer, he fixes it (although, not many engineers would notice the misspelling
) He also notices that the SOP/ WI states that an operator must cut the flash on both ends prior to placing in the box. Sometimes there is not flash on both ends so like a good engineer, he adds, "if flash is present"
Now there is no need to redistribute all those SOPs and Work Instructions to the cells again, but technically this is a new version and needs to become Rev. B (or 2 or whatever)
Now according to your system and theory, he (or the Quality Coordinator) must go around to all 3 buildings and 8 cells and retreive the obsolete documents (per the ISO standard as it relates to obsolete documents). It is pretty much guaranteed that they will miss one and that will be the one that the auditor will find. Who knows the cell leader may have printed up 20 copies for all members of the cell to review during the training, maybe he only printed it once. Who knows.
This way he can gather all the required copies and make sure that only the most current revision is being used.
Just some thoughts.....
) He also notices that the SOP/ WI states that an operator must cut the flash on both ends prior to placing in the box. Sometimes there is not flash on both ends so like a good engineer, he adds, "if flash is present" Now there is no need to redistribute all those SOPs and Work Instructions to the cells again, but technically this is a new version and needs to become Rev. B (or 2 or whatever)
Now according to your system and theory, he (or the Quality Coordinator) must go around to all 3 buildings and 8 cells and retreive the obsolete documents (per the ISO standard as it relates to obsolete documents). It is pretty much guaranteed that they will miss one and that will be the one that the auditor will find. Who knows the cell leader may have printed up 20 copies for all members of the cell to review during the training, maybe he only printed it once. Who knows.
This way he can gather all the required copies and make sure that only the most current revision is being used.
Just some thoughts.....
A word of caution: It's best to make sure that documentation is written correctly in the first place. If there's no one in the building who can write (and you're right, most engineers can't) then someone should be brought in to proofread before release. Be ever mindful of changes in punctuation and grammar that can alter meaning.