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

S

super-adik

#11
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.

Thanks Ronen! We are going to have a meeting today to discuss this project. I will ask for specific details.

I wonder if anyone has a procedure or at least a flow chart of how dock to stock works.

Thanks,
Norman
 
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Ronen E

Problem Solver
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#12
Thanks Ronen! We are going to have a meeting today to discuss this project. I will ask for specific details.

I wonder if anyone has a procedure or at least a flow chart of how dock to stock works.

Thanks,
Norman
Hi,

I don't have a procedure or a flow chart available for sharing, but I can definitely try to help you go through the process.

Once everyone is in agreement on what "Dock to Stock" means in your specific context, and what the end goals are (all this should be documented and signed-off by senior management), start by listing the subject suppliers. If you don't already have a shortlist (I believe management would already know who are the suppliers of interest), start by identifying all suppliers regularly supplying you for over X years. Pull out detailed data on their quality performance and analyse the trends. Those with long acceptable performance and an upward / stable trend are candidates. If candidates are already identified, analyse them in a similar manner to establish feasibility. If the indicators are not good, go back to senior management and renegotiate. DO NOT move forward unless the suppliers qualify, otherwise the lesson will be painful and you might end up as the scapegoat.

Next, analyse each supplier in terms of supply portfolio and criticality of supplied components / materials (how critical are the goods to the finished device safety / performance). Continue from there to establish requirements for qualifying for Dock to Stock, on an individual item basis. The more critical the item, the more demanding the qualification should be. Work with the suppliers to gather information and analyse, audit remotely and/or on site as required, document everything. Negotiate QA controls and logistic arrangements with the supplier and capture in an agreement / contract. Devise your own procedures and controls for implementation, and a plan for break-in. Implement and monitor. Fine tune. Review after 3 months, 6 months and 12 months.

In all that process don't forget to follow all your other applicable SOPs like Document Control, Change Control, Purchasing Controls (suppliers selection and approval), Process Controls etc.

Cheers,
Ronen.
 
S

super-adik

#13
Hi,

I don't have a procedure or a flow chart available for sharing, but I can definitely try to help you go through the process.

Once everyone is in agreement on what "Dock to Stock" means in your specific context, and what the end goals are (all this should be documented and signed-off by senior management), start by listing the subject suppliers. If you don't already have a shortlist (I believe management would already know who are the suppliers of interest), start by identifying all suppliers regularly supplying you for over X years. Pull out detailed data on their quality performance and analyse the trends. Those with long acceptable performance and an upward / stable trend are candidates. If candidates are already identified, analyse them in a similar manner to establish feasibility. If the indicators are not good, go back to senior management and renegotiate. DO NOT move forward unless the suppliers qualify, otherwise the lesson will be painful and you might end up as the scapegoat.

Next, analyse each supplier in terms of supply portfolio and criticality of supplied components / materials (how critical are the goods to the finished device safety / performance). Continue from there to establish requirements for qualifying for Dock to Stock, on an individual item basis. The more critical the item, the more demanding the qualification should be. Work with the suppliers to gather information and analyse, audit remotely and/or on site as required, document everything. Negotiate QA controls and logistic arrangements with the supplier and capture in an agreement / contract. Devise your own procedures and controls for implementation, and a plan for break-in. Implement and monitor. Fine tune. Review after 3 months, 6 months and 12 months.

In all that process don't forget to follow all your other applicable SOPs like Document Control, Change Control, Purchasing Controls (suppliers selection and approval), Process Controls etc.

Cheers,
Ronen.


Thank you so much Ronen! I will use these steps as my guide. :thanx::thanx::thanx::thanx::thanx::thanx::thanx::thanx::thanx::thanx::thanx::thanx:
 
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