Subcontractor's subcontractor - Outsourcing of Sterilization to a sub tier Supplier

[SueReb]

We outsource the sterilization through our packaging subcontractor. Therefore, the sterilization facility is not on our ASL because they are subcontracted by our packaging subcontractor. We are being told that they need to be on our ASL because they sterilize our product. Is this accurate? We do not have control over the sterilization facility because we do not submit purchase orders for the sterilization process. A bit more clarification is greatly appreciated

 

[optomist1]

II must confess, I have absolutely zero experience in the Medical Info or Medical Tech field...however, this matter appears to be one of imposing or requiring a Tier 2?? to comply with the same requirements as those for a Tier 1...and in a broader sense this is just sound supply base management and compliance...some folks will calls this requirements flow down, which it is in large part,

my three Euros worth, hope this helps..
Optomist1

 

[SueReb]

II must confess, I have absolutely zero experience in the Medical Info or Medical Tech field...however, this matter appears to be one of imposing or requiring a Tier 2?? to comply with the same requirements as those for a Tier 1...and in a broader sense this is just sound supply base management and compliance...some folks will calls this requirements flow down, which it is in large part,

my three Euros worth, hope this helps..
Optomist1

Thank you for your input, greatly appreciated. We will take the approach of listing the sub/subcontractor on our ASL with a comment that the sub/sub-contractor is controlled by the sub-contractor under their QMS.

 

[planB]

Presuming that "ASL" means "Approved suppliers list": in my humble opinion, you do have a good reason to keep this sub-contractor off your list, simply because they are not approved by you through a formal (quality) agreement. In my experience that works and is accepted, provided that you demonstrate adequate control differently, e.g. through your order specification containing a section defining sterilization and/or an adequate contract with the packaging facility: ultimately you do have to exert control over the sterilization process your products are subjected to, no matter how "far" sub-contracted this critical process is. And you do want to make sure in your agreement with the contract packaging facility, that they in turn have an adequate system in place both controlling the contract sterilizer in general, as well as capable of translating your specific sterilisation requirements to them.

HTH,

 

[SueReb]

Presuming that "ASL" means "Approved suppliers list": in my humble opinion, you do have a good reason to keep this sub-contractor off your list, simply because they are not approved by you through a formal (quality) agreement. In my experience that works and is accepted, provided that you demonstrate adequate control differently, e.g. through your order specification containing a section defining sterilization and/or an adequate contract with the packaging facility: ultimately you do have to exert control over the sterilization process your products are subjected to, no matter how "far" sub-contracted this critical process is. And you do want to make sure in your agreement with the contract packaging facility, that they in turn have an adequate system in place both controlling the contract sterilizer in general, as well as capable of translating your specific sterilisation requirements to them.

HTH,

Thank you for the insight!!!
First, yes ASL=Approved Supplier List. Our Auditor is stating that we need to have the sterilization facility listed on our ASL because it is a critical process to our product. Our concern is that "we" do not control that sub-contractor under our QMS. We do have the controls defined in the Quality Agreement and we do receive all sterilization certifications as part of the Device History Records. We are hesitant to add them to our ASL but also do not want to be issued a non-conformance due to this.

 

[Sidney Vianna]

We do not have control over the sterilization facility because we do not submit purchase orders for the sterilization process.

Of course you can EXERCISE control over the sterilization service provider via the agreement you have with the packaging vendor, which would mandate them to flowdown the proper requirements. You can and should specify the proper requirements onto that critical vendor. And nothing prevents you from having a direct contractual relationship with the sterilization house, if needed.

 

[planB]

You may want to challenge your (notified-body?) auditor which controls you are actually lacking by your established quality agreement, and how putting a sub-contractor on a rather arbitrary list would resolve this.

 

[Sinus Tarsi]

We outsource the sterilization through our packaging subcontractor. Therefore, the sterilization facility is not on our ASL because they are subcontracted by our packaging subcontractor. We are being told that they need to be on our ASL because they sterilize our product. Is this accurate? We do not have control over the sterilization facility because we do not submit purchase orders for the sterilization process. A bit more clarification is greatly appreciated

Hello there! Same situation here. We have our packaging subcontractor listed and underneath we show the sterilizer, as well as their ISO Cert information and FDA Reg. information. Also, one of the things we were written up for - IQ is the sterilizers responsibility, OQ is also the sterilizer's responsibility BUT you must have documentation on hand proving this is being done and there are no changes to the sterilization of your devices.

 

[SueReb]

Hello there! Same situation here. We have our packaging subcontractor listed and underneath we show the sterilizer, as well as their ISO Cert information and FDA Reg. information. Also, one of the things we were written up for - IQ is the sterilizers responsibility, OQ is also the sterilizer's responsibility BUT you must have documentation on hand proving this is being done and there are no changes to the sterilization of your devices.

Thank you so much for this information!!! I will reach out to our sub-contractor to ensure that I receive that documentation to have on file.

 

[I_Moy]

You definitely need to show how you exercise control over your sterilizer (as a critical outsourced process), that control may be via your packaging provider but you still must show that level of control. So, as an auditor I would be expecting you to show me how you ensure that your packaging supplier is controlling their supplier (the sterilizer) to ensure all requirements are being met (change notification, etc), e.g. sterilization should be listed in their scope of qualification, in your quality agreement with them and through your audit of them it should cover their control of the sterilization facility. Separate to supplier management requirements sterilization is a critical process so from a design control perspective you should have the sterilization validation documents within your DHR and have a method to ensure re-validations are completed as necessary.