D
Davey
Guidance for Developing Inspection Criteria
I work at a facility that is manufactuing an implantable medical device. Manufacturing consists of building a number of sub-assemblies then combining these sub-assemblies into the final assembly.
One area that requires improvement is inspection criteria. There are numerous in-process and final inspections included in the overall manufacturing process. However, the inspection criteria have not been very well defined or written. For example, an inspection may require confirming the dimensions of a sub-assembly, but not ensuring the sub-assembly actually does what it is supposed to do.
I would like to begin this project by developing a guideline for writing inspection criteria. Obviously, the critieria have to be appropriate the item that is being inspected, but having some general guidance for developing the criteria is necessary. The guideline can then be used for identifying and selecting the critical items to be inspected at each inspection.
So far, I have come up with the following broad categories:
- visual (inspect for obvious damage, dirt, workmanship, etc.)
- dimensional (confirm critical dimensions by measurement or fit check)
- functional (make sure the thing does what it is supposed to do)
- documentation (including labelling)
Does anyone have any suggestions, ideas or comments on developing inspection criteria?
I work at a facility that is manufactuing an implantable medical device. Manufacturing consists of building a number of sub-assemblies then combining these sub-assemblies into the final assembly.
One area that requires improvement is inspection criteria. There are numerous in-process and final inspections included in the overall manufacturing process. However, the inspection criteria have not been very well defined or written. For example, an inspection may require confirming the dimensions of a sub-assembly, but not ensuring the sub-assembly actually does what it is supposed to do.
I would like to begin this project by developing a guideline for writing inspection criteria. Obviously, the critieria have to be appropriate the item that is being inspected, but having some general guidance for developing the criteria is necessary. The guideline can then be used for identifying and selecting the critical items to be inspected at each inspection.
So far, I have come up with the following broad categories:
- visual (inspect for obvious damage, dirt, workmanship, etc.)
- dimensional (confirm critical dimensions by measurement or fit check)
- functional (make sure the thing does what it is supposed to do)
- documentation (including labelling)
Does anyone have any suggestions, ideas or comments on developing inspection criteria?