Rob Packard For every dock-to-stock program, the key to success is data. You need data to determine if the vendor is likely to delivery product within specifications. In addition, you need to know the potential severity of harm if the component is out of specification. Ribbon stock will not cause harm. Implants can cause harm. Third, you periodically should verify that things have not changed. Vendors are people and you should periodically check-in with those people to make sure they are still doing their best to make good product for you. Check-in does not have to be an audit on-site. You can do remote audits and you can use sampling of inspection data on a less frequent basis (e.g., skip lots).

Jonathan Wacks Don't forget a Risk Mgmt exercise assessing each component. Risk + History = Action.

Jonathan Wacks As always, Rob is on the money. Another crucial element: Risk Mgmt. Boxes and bags: Low Risk. Rotating Crankshafts: High Risk. Create three categories, confirm no historical issues with the low-risk items, and Dock-to-stock them. Medium Risk:Skip lots, then DTS...

Lawrence (Larry) Ross Depends upon risk. I've operated for 15 years in a Class II/III implant environment and you need a tight supplier quality program to start. FDA is all over supplier controls-but with moving in the MDSAP direction, risk-based is the way to go. What you can do will depend upon the criticality of what you are receiving. Some cases you may validate the process at the supplier, in other cases you may need to do some sampling, or other verifications. Each situation is different. What I can say is to start, have a strong scientific rationale for what you are doing and demonstrate that you have the upstream process (supplier) well under control.

Agree with Mr. Packard, also you can implement a PPAP (Production Part Approval Process) program

Karen Boyd, ASQ CQA Categorizing your supplies / suppliers according to risk levels will allow you to identify what low risk items may be dock-to-stock and higher risk items require critical inspections. Risk to finished product / end use of the device and conformance to safety and performance requirements are paramount.

Karen Boyd, ASQ CQA Concur with Lawrence (Larry) Ross

Gordon Skiba Off the shelf (OTS) components do not require inspection beyond verification. Few medical device manufacturers have the volume necessary to influence an OTS manufacturer, whereby your decision is to use them or find a different source. You're better off validating your high risk components, or conduct one hundred percent (100%) functional testing to alleviate incoming/in-process inspection. The only components you should inspect at receiving, are those with lengthy lead times and/or high cost.

Lawrence (Larry) Ross Remember dock to stock and skip lot needs data to prove you have the basis for reducing inspection-validate! Also, go beyond the typical QMS audit at the supplier. In Med Device, this concept is starting to take off and now has FDA full support. Similar to Military (NADCAP), there is now MEDACRED. Both are administered by PRI. The concept is the same-they focus on control of the critical processes (vs. just std QMS).

I'm from the pharma world, but I've spent the last eight years managing starting materials for a company engaged in contract R&D. Ultimately, EVERYTHING needed to be in a form that could be included in a tech transfer program. This involved managing 300+ different suppliers. From a pharma perspective - which may not be totally applicably to devices - I would start as follows. 1) Understand all the processes involved in getting a part from the supplier to manufacturing. 2) Review and update material specifications. 3) Optimize inspection processes, including cal & maintenance of any instruments required. We did some RM activities, the biggest of which was staying away from Indian and Chinese suppliers; too many problems in those places from a compliance perspective currently.