Pre-production units & Purchasing/Supplier/Material controls

[Hi_Its_Matt]

What type of purchasing controls, supplier controls, material/component traceability, etc. is required (or recommended) for pre-production prototypes? Does the answer differ for units used for design verification? What about units intended for pre-commercial release human use?

The FDA says:

Devices approved under an investigational device exemption (IDE) are exempt from the Quality System (QS) regulation, except for the design control requirements under §820.30. However, the sponsor may state an intention to comply with other parts of the QS regulation. The extent to which the Quality System regulation will be followed in manufacturing the device must be documented in the sponsor’s IDE records [§812.140(b)(4)(v)].

This leads me to believe that, at least in the eyes of the FDA, you aren’t required to apply purchasing controls, supplier controls, material traceability etc. during the pre-production phase.

For context: my current company requires purchase orders and maintenance of purchasing records for far more than I think any standard/regulation requires, and I’m trying to lean it out. We are a small, design consulting firm, working only in pre-production stage of device lifecycle. I have asked the president and finance, and they say there is no non-quality related reason for preferring POs over direct payment (i.e., credit cards).

Note: I’m posting this under the 13485 sub-forum, but I’m also interested in FDA QSR and EU MDR considerations.

 

[Tidge]

I think you've gotten it right. I've worked with (design & development) groups that required somewhat strict supplier controls on pre-production prototypes, but it was NOT because of design controls. The more stringent than necessary controls (for pre-production prototypes) existed primarily because of bad discipline in the purchasing department (not entirely that deptartment's fault)... think: "I see that we bought material from this supplier, so I guess we can buy just about anything from them."

As a small design consulting firm, as long as you contracts (with your customers) are very clear about what you will be transferring to them, and it is not a design for verification (or a finished good!) I can't see why (from a regulatory PoV) you would need to implement particularly stringent controls at this stage. There of course may be financial reasons... just as an example: it is not unheard of that in the case of injection molded parts that a manufacturer will be tempted to turn the prototype tools into the production tools. That isn't a good practice, but in the case of a supplier doing anything "custom" you probably want to at least have some documentation of what was done to the prototypes for eventual reconstruction of units for design verification.

 

[yodon]

@Tidge answered the purchasing question nicely. Let me touch on the design controls aspect.

Sounds like we're very similar to you (contract design). We put prototypes (whatever the use is, they're not production) under design controls if anything leaves the shop or is used for some regulatory aspect (trials, V&V, etc.). This is both to protect us (in case customer makes changes) and to enable us to recreate the configuration if any issues arise.

In terms of production -v- production-equivalent, that can get messy. Machined parts -v- molded -v- 3D printed could have some differences so you need to be able to justify what you used is relevant. Further, biocompatibility can be affected by colorants. Design controls don't require production equivalence for design verification (they do for validation) but the further you diverge from production-equivalent, the greater the risk of production deviating from what was verified.

 

[Hi_Its_Matt]

As a small design consulting firm, as long as you contracts (with your customers) are very clear about what you will be transferring to them, and it is not a design for verification (or a finished good!) I can't see why (from a regulatory PoV) you would need to implement particularly stringent controls at this stage.

But what about if the units are to be used for DV? Our process is that, when a design is to be subject to formal DV activities, all drawings, BOMs, part specs, etc. needs to be under formal configuration management (i.e., released in our document control system). But do we need to keep records of the purchases of the constituent parts/components that our DV prototypes are built from? Or records of the receiving inspection of those parts/components? Should those components/parts be traceable back to the manufacturer's production data? Do the suppliers of those parts need to have gone through a formal evaluation/qualification process?

We put prototypes (whatever the use is, they're not production) under design controls if anything leaves the shop or is used for some regulatory aspect (trials, V&V, etc.). This is both to protect us (in case customer makes changes) and to enable us to recreate the configuration if any issues arise.

I've always thought about documentation being under design controls, rather than physical prototypes. But I think I get what you're saying. We have trackers analogous to manufacturing travelers that accompany each prototype and record its build history and any changes to it.

 

[yodon]

But do we need to keep records of the purchases of the constituent parts/components that our DV prototypes are built from?

That gets the big "it depends." If, say, the material is the focus, for biocompatibility, for example, then yes, you would want to have good records going back to purchase (my opinion - don't think I've seen anything in the regs / guidance docs addressing it specifically). Another example might be laser diodes - you probably want good traceability there. If you just have commercially available screws, probably not.

 

[Tidge]

"It depends" really is the correct answer. From a regulatory perspective (NB: I am NOT a regulatory auditor) it is far less likely that a sloppy set of supplier controls ("sloppy" is offered as an adjective for an opposite extreme of "rigorous", I am not using it to pass judgement) will damage the quality of design verification... in my mind sloppy supplier controls are most likely to manifest problems if there are multiple units being used for diverse verification efforts. Think: "Unit A passed verification tests of subsystem 1, but Unit B (testing subsystem 2) showed flaky behavior from subsystem 1"

If there is a rigorous design validation plan (requiring "production equivalence"), my primary worry about NOT implementing necessary (on a sliding scale, of course) supplier controls ASAP is that there may be a significant time gap between OE of design verification and execution of design validation (and eventually production). I have secondary concerns that delaying of a necessary step (supplier controls) in marketing safe and effective and consistently performing medical devices is the first step on the path of ignoring that necessary step. If the time crunch is such that the prototypes are going to be used for formal design verification, it is easy for to imagine that other steps of the process may be similarly motivated. (again, no judgement... it's just that I worry about business risks in addition to compliance and safety risks.)

 

[somashekar]

What type of purchasing controls, supplier controls, material/component traceability, etc. is required (or recommended) for pre-production prototypes? Does the answer differ for units used for design verification? What about units intended for pre-commercial release human use?

The FDA says:


This leads me to believe that, at least in the eyes of the FDA, you aren’t required to apply purchasing controls, supplier controls, material traceability etc. during the pre-production phase.

For context: my current company requires purchase orders and maintenance of purchasing records for far more than I think any standard/regulation requires, and I’m trying to lean it out. We are a small, design consulting firm, working only in pre-production stage of device lifecycle. I have asked the president and finance, and they say there is no non-quality related reason for preferring POs over direct payment (i.e., credit cards).

Note: I’m posting this under the 13485 sub-forum, but I’m also interested in FDA QSR and EU MDR considerations.

This whole stuff is based on the risks associated with the medical device in question. Not all suppliers are new and not all pre-production proto are inventions. It goes to see what additional controls (if any) are required for the case in question. This is where the clause comments on reevaluation.