Implementing Dock-to-Stock when regulated by ISO 13485 and 21CFR820

V

Vbenck

#1
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:
 
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M

MIREGMGR

#2
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.
 
V

Vbenck

#3
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.
 
K

Katydid

#4
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....)
 
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S

Sirius.Black

#5
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:
 
V

Vbenck

#6
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!
 
I

Ironcountry

#7
How did the effort go? My company is interested in the same so would like to know how it went.
 
V

Vbenck

#8
Well, honestly it was a struggle at first. We started out with very, very tight controls which made it difficult to move much of anything on D-t-S. A few months ago, we took another look at this and decided with the vendors we have today and the history we have with them we could ease up on the criteria. In the first round, we said any part that was custom, had critical labeling, etc was never eligible. Since then we changed it to say everything is eligible as long as we have the 10 acceptable vendor lots, it is the same revision as the accepted vendor lots and has not had any NCR's or SCAR's asspociated with it. Basically, we decided we have enough data on most parts to show proof of why they should be eligible.
It is working well for us. I should say, working better than we anticipated. We have been through a couple audits since then and have not had any issues.
Good Luck!!
 
S

super-adik

#9
Hi All,

I was assigned to established a procedure to implement dock to stock. They expect me to have it ready and be implemented by the end of next month (Oct 2014). We are also under ISO 13485 and 21CFR820 regulations.

Do you have samples of a procedure or flow chart of what needs to be evaluated? Can you please guide me where and how to start?

I started a flow chart. I'm not sure if I am on the right path. Please see attached.

Thanks in advance!
 

Attachments

Ronen E

Problem Solver
Staff member
Moderator
#10
Hi All,

I was assigned to established a procedure to implement dock to stock. They expect me to have it ready and be implemented by the end of next month (Oct 2014). We are also under ISO 13485 and 21CFR820 regulations.

Do you have samples of a procedure or flow chart of what needs to be evaluated? Can you please guide me where and how to start?

I started a flow chart. I'm not sure if I am on the right path. Please see attached.

Thanks in advance!
Hi,

I suggest you start by establishing what your management expects from "Dock to Stock".

IMO Dock to Stock is about building evidence-based confidence that the supplier will only ship good parts, hence no incoming inspection or screening would be required. At all. The focus is on the supplier's QA, and usually on long-term acquaintance too.

What your flowchart represents is a receiving scheme of sorts. IMO it misses the concept of Dock to Stock, but before going anywhere you *must* be absolutely sure what your management means and expects. If your flowchart is along the lines of what you were communicated, perhaps your company is not ready for Dock to Stock.

Cheers,
Ronen.
 
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