Our company is in the process of trying to implement a Dock-to-Stock program, but we are having difficulty getting this going. We are regulated by ISO 13485 and 21CFR820 so making sure we comply with all their requirements while making the program as simple as possible has been frustrating (maybe we make it harder than it really is). :frust:
I would really appreciate it if anyone has any really good procedures, flow charts or criteria for parts eligibility that they could share with me that we can use as a guideline or at least a starting point. :thanks:

How are you approaching the second sentence of 21 CFR 820.80(b) "Receiving Acceptance Activities": "Incoming product shall be inspected, tested or otherwise verified as conforming to specified requirements" ?

We've been gigged in the past for having a procedure that, for certain material types and based on vendor qualification and material track record, recognized the seller's inspection (of material that they received from the original maker) and certification of specification compliance as being an acceptable substitute for a receiving inspection by us.

We were thinking along those lines we just weren't sure it met the requirement. We were planning to have our QC inspectors sign the Inspection section of the Receiver to say the vendor part number, avl all match what is being received. We then were going to put criteria in our non-conforming procedure to say that if a discrepancy is found on the mfg floor the part will be removed from dock-to-stock status and will have to go through the qualification process again once it has passed 5 normal inspections.

My company is qualified as a dock to stock supplier with some of the largest orthopedic companies in the world, but recently controls have been tightened by our customers. It seems the FDA has been pushing vendor control as one of their "hot button" issues. I would recommend being sure the companies and/or products you are approving as dock to stock not only pass inspections for 5 lots, but you have additional controls and types of justification for qualifying these vendors. It may be an annual audit schedule for the product and/or the vendor's manufacturing facility, or justification by documented past and current performance, statistical analysis, or other methods that fit with they type of supplier. I would not only consider the initial qualification requirements, but the long term verification of quality conformance. (Maintain....)

Hi There -

I too am very interested in establishing a Dock-to-Stock program for the med device company I work for. Prior to DS implementation the vendor had to have been qualified via a standard site audit...etc. Historically, I have attempted implementing supplier qualification systems based on 5 consecutive perfect lots (perfect meaning 100% inspection acceptance). Said vendor would then be placed on the Dock-to-Stock approved w/ contigency vendor list subject to random lot inspections of 3 lots over the next 10 received; (however, every received lot was required to be accompanied by COCs, COTs, and the supporting data.) These 3 lots would be sampled according to standard ANSI sampling procedures or C=Zero methods. If the vendor met requirements accordingly then they would receive final approval status for DS. henceforth and so on, I required the vendors to continue to submit the COCs and COTs and - depending on the criticality of the parts - would require continued submission of the supporting data and would resort to a random inspection of received shipments of 1 of 10 lots for the forseeable future. If ever a lot failed inspection then the vendor had to have a SCAR issued and depending on the nature of the failure may be subject to a repeat of the whole process.
I must emphasize, though, that one must adequately assess the criticality of the parts in question and be able to demonstrate a valid justification for this type of practice as well as to demonstrate that the process is in full control to pass the muster of an audit.:agree:

Sirius.Black -
Thank you for your comments. We are implementing a process very similar and have our first 10 parts going on Dock to Stock. We will see what happens!
Thanks!