For those of you that may be a bit stressed this morning, I offer a bit of Quality v. Production humor.
QA motto: When in doubt, throw it out.
Production motto: When in doubt, ship it out.
All the Quality people chuckle and the Production folks groan..
On the serious side.. I am not familiar with medical device regulations, but it would seem that if there are arguments, then perhaps the requirements are not as clearly defined as they could be.
Allowed dispositions are clearly defined in the various standards..
A form of waste is to 'over specify' a product. This is where a well defined set of technical, regulatory and customer requirements and needs is essential.
It will give all parties a clear set of standards against which to make dispositions. I don't think the 'who' is nearly as important as the 'why' in identifying disposition.
When considering disposition, typically, Quality clearly identifies the nonconformity and provides pertinent information regarding it.
Production and/or Manufacturing Engineering determine if it can be brought into compliance and at what cost.
Product Engineering typically determines if use-as-is is acceptable.
Quality and/or Sales/Customer Service typically perform the customer notification/ approval process.
With a medical device, someone from legal may need to give input depending on the product risk.
Hope this helps..
Sr. Quality Technician, III
ASQ CMQ/OE, ASQ CQE
725 E University Dr
McKinney, TX 75069
Phone: 972.547.6020 : Ext 1262
CONFIDENTIALITY NOTICE - The contents of this message and the attachments are confidential and are for the exclusive use of the intended recipient(s). If you are not an intended recipient, please immediately delete it without reading it and without further distribution or disclosure. Any further distribution of this message to others is subject to this Confidentiality Notice and/or any confidentiality agreement or non-disclosure agreement in effect that covers the information contained in the message and any attachments.