During our ISO 9001 internal audit it was found that a work instruction called out associate to gage check part every 1/4 hour. Associate knew this yet was only checking and documenting it once per hour. When asked why she indicated someone told her to only check it once per hour but she could not remember who told her this. In a case of not following work instructions what would you write this finding under?
Question on finding • Failure to follow Work Instructions
- Thread starter qcman
- Start date
I would cite the work instruction requirement that is not being followed.
Basing everything on the standard inevitably leads to an "ISO says so..." kind of mindset. Your internal requirements should be designed such that the requirements of the standard are satisfied if the requirements are met. Your confusion here is also a good reason. If the requirement is rigid (measure every 15 minutes) and for some reason the requirement can't be met, you've painted yourself into a corner.
I think Cari has provided the best solution. Cite your own requirement. If there is corrective action to be done as a result of the finding, part of it should be determining how and if the requirement may be superseded if need be.
If you want to connect to the standard, cite against 7.5.1 (doc info) or better yet, 8.1 (control planning), which is a little more detailed. Either way, it's failure to follow the work instruction. Now make sure they review the WI to determine if 1 per hour is good -- don't do unnecessary work. Good luck.
1/4 hour inspection is pretty standard on all operations / work instructions.
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