Process owner for Supplier Controls

#1
Hi all. New to this forum, and appreciate any guidance that is offered.

Who is typically the process owner for Supplier Controls under ISO-13485 (ie: approval, supplier agreements, re-evaluation, etc.)? Purchasing or Quality?
 
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yodon

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Super Moderator
#2
I don't think you can necessarily define "typical" given the variety in organization sizes, management approaches, etc. The bottom line is who has the competence to do the work and if is it being effective. What may be considered "typical" may not work for your organization.
 

William55401

Quite Involved in Discussions
#3
Collaboration (also know as teamwork) is key. A Quality function typically partners with an Operations function (Purchasing, Supply Chain, Sourcing-- so many names......but I digress). for example, he Operations function would own the procedure for issuing purchase orders against specifications. Ops would lead on selection. Quality can veto suppliers not meeting expectations -- this is so important. Quality would also own procedures related to Quality Agreements., Supplier CAPA, supplier audit, etc. Ops and Quality have a voice in each others work. The mindset has to be this is "our system" and not one of yours or mine. There is a lot more detail here but hope this approach helps. Have fun, enjoy the ride!
 

Sidney Vianna

Post Responsibly
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Admin
#4
Who is typically the process owner for Supplier Controls under ISO-13485 (ie: approval, supplier agreements, re-evaluation, etc.)?
Since the Process Owner should be knowledgeable about the issue at hand, it seems to me that someone from the quality function would be much better positioned to lead and manage such critical process. In my experience, a typical buyer or someone representing the procurement function are, mostly ignorant about supplier performance issues and limit themselves to manage pricing, commercial agreements and delivery commitments. As an auditor, I have seen numerous cases of botched relationships with suppliers because the buyer assigned to them created all kinds of bottlenecks in the communication between the two organizations.
 

William55401

Quite Involved in Discussions
#5
Sidney, Management Responsibility has the key enabling role. Partnership, teamwork and collaboration begins at the leadership level. If the procedures are assigned to a buyer with no support, that is a recipe for disaster. If ownership is delegated down to the lowest level and the outcome is not acceptable, looking at that low level owner for ultimate responsibility is a big mistake.
 
#6
I don't think you can necessarily define "typical" given the variety in organization sizes, management approaches, etc. The bottom line is who has the competence to do the work and if is it being effective. What may be considered "typical" may not work for your organization.
Thank you. Was just looking for opinions on how others operate, to help with our decisions.
 
#8
Collaboration (also know as teamwork) is key. A Quality function typically partners with an Operations function (Purchasing, Supply Chain, Sourcing-- so many names......but I digress). for example, he Operations function would own the procedure for issuing purchase orders against specifications. Ops would lead on selection. Quality can veto suppliers not meeting expectations -- this is so important. Quality would also own procedures related to Quality Agreements., Supplier CAPA, supplier audit, etc. Ops and Quality have a voice in each others work. The mindset has to be this is "our system" and not one of yours or mine. There is a lot more detail here but hope this approach helps. Have fun, enjoy the ride!
Thank you.
 

John Broomfield

Leader
Super Moderator
#9
Ask top management to delegate their authority to process owners. They should select folk who are made competent by the recruiting and training processes.

Personally, I’d want to ensure purchasing staff did a lot more than issuing POs as procurement professionals.
 

Tagin

Trusted Information Resource
#10
Who is typically the process owner for Supplier Controls under ISO-13485 (ie: approval, supplier agreements, re-evaluation, etc.)? Purchasing or Quality?
In my view, it should be the group that is responsible for selecting suppliers, and having to deal with them. Quality can, and should, advise and assist in designing the supplier controls process, and in seeing that supplier metrics are monitored via KPIs, management review, etc.
 
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