Here is my situation -
I am with a medical device manufacturer. However, we have products that are not medical devices. My question is with these items.
1. Recently through internal audits we realized that we are performing inspections that are not adding value, but rather have always been done this way (I know - you've heard it before). The product has over 300 SKU's, but they all require this activity.
2. In my investigation, we have not had any customer issues over the last 18 months - probably longer. No internal non-conformances either.
3. This activity requires significant QM manpower.
I am interested in eliminating this action, as based on my extensive evaluation it is not adding value.
If I were to issue a concession (temporary) for removing this requirement with a plan of action for doc updates, training, system mods. Would you consider this a low risk approach?

I am with a medical device manufacturer. However, we have products that are not medical devices. My question is with these items.
1. Recently through internal audits we realized that we are performing inspections that are not adding value, but rather have always been done this way (I know - you've heard it before). The product has over 300 SKU's, but they all require this activity.
2. In my investigation, we have not had any customer issues over the last 18 months - probably longer. No internal non-conformances either.
3. This activity requires significant QM manpower.
I am interested in eliminating this action, as based on my extensive evaluation it is not adding value.
If I were to issue a concession (temporary) for removing this requirement with a plan of action for doc updates, training, system mods. Would you consider this a low risk approach?
